Fujifilm Endoscope   Models     ED-250XL5  ED-250XT5  ED-450XT5  ED-450XL5    Product Usage:  This product is a medical endoscope for the duodenum and upper GI tract. It is intended for observation, diagnosis, and endoscopic treatment of the esophagus, stomach and duodenum. This product is not used for any other purposes.
Fujifilm is conducting a corrective action due to an FDA inspection.
Fujifilm Endoscope   Model ED-530XT      Product Usage:  This product is a medical endoscope for the duodenum and upper GI tract. It is intended for observation, diagnosis, and endoscopic treatment of the esophagus, stomach and duodenum. This product is not used for any other purposes.
Fujifilm is reporting a corrective action due to an FDA inspection.
For Manual Code 202B1259902B, 140417-3.0-DT-US2 - 157 manuals were distributed  For Manual Code 202B1237697D, 140408-5.0-DT-US2 - 103 manuals were distributed
Zlotoklos brand Ciastka maslane w czekoladzie (Butter cookies in chocolate), 12.3 oz (350 g).  Product is packaged in a plastic tray with foil overwrap, 12 packages per case.
Presence of undeclared milk: the product lists butter as an ingredient but does not list milk as the source of the butter as required by FALCPA (Food Allergen Labeling and Consumer Protection Act).
US Distribution to one customer in Missouri.
FFR Link-FFR Signal Processing Module, Material Number H7495551000  It is intended to condition physiological signals from measuring devices (BSC Pressure Guidewire or an external pressure transducer), transmit and receive via radiofrequency, and recondition the signals so they can be displayed on and/or recorded in a receiving device (iLab POLARIS Multi-Modality Guidance System or other monitoring device). The physiological signals can also be distributed by cable
The device history record (DHR) was missing its test documentation for final HIPOT (high potential) electrical testing.
Implant Direct Sybron Manufacturing, LLC
Worldwide Distribution - USA (nationwide) Distribution to the states of :  AZ, CA, CO, CT, FL, ID, IL, KS, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA., and to the countries of :  Canada, Netherlands, Spain, Great Britain, Germany and Switzerland.
Spectra-System/Legacy Guided Surgery Handle Kit, Device Listing Number D245883.    The Guided Handle Kit (G-HK) allows clinicians to drill through a surgical guide to create an osteotomy for implant placement with the precision and accuracy as designed with treatment planning software. The G-HK consist of 4 guide handles with inserts attached on each end. Each insert has an opening that matches the diameter of our surgical drills. The insert portion of the guide handle fits intimately into the guide sleeve that is embedded into a surgical guide.
The inside diameter of the 2.3mm small drill guide inserts have a smaller diameter than the specifications require.
Lot 65249, Sequence Number HE G-HKRev01, Device Listing Number D245883.
Worldwide Distribution - US (nationwide) and Internationally to Canada, China, France, Germany, India, Israel, Italy, Russia, Saudi Arabia, Spain and the United Kingdom.
Herga foot switch, model 6289-WS, a component of the ROSA Robotized Stereotactic Assistant Surgical Device, Model 2.5.8.  The firm name on the foot switch label is Herga Electric Limited, Bury, St. Edmunds, Suffolk IP32 6NN.  ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments. It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate
Complaints were received reporting the system would freeze/shut down while in Fulgurate mode.
US Distribution to: TX, PA, VA, CA, NY, IL, MI, NC, SC and KS.
BD Needle 22GA 1-1/2in SafetyGlide(TM) Non Sterile, Bulk, REF 301701    The BD SafetyGlide(TM) needle is intended to be used for general purpose injection, aspiration of fluids from parts of the body below the surface of the skin, injection into intravenous ports and tubings external to the patient. The needle stick prevention feature of the device contains a mechanism that covers the needlepoint after use. Bulk Non Sterile configuration is intended for further manufacturing, processing or repackaging
Presence of loose polypropylene foreign matter above release specification.
ANDROPHARM STEN Z (2, 17a-Dimethyl-17b-hydroxy-5a-androst-1-en-3-one 10mg and 17b-hydroxy-2a, 17b-dimethyl-5a-androstan-3-one azine 10 mg) capsule, packaged in 60-count bottle, Andropharm.com, UPC: 6 42125 50294 8
Marketed without an approved NDA/ANDA: product label states it contains anabolic steroids.
ANDROPHARM M1 ALPHA (Methyl-1-Etiocholenolol-Epietiocholanollone 20 mg) capsule, packaged in 60-count bottle, Amazon.com,  UPC 6 42125 50292 4
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling firm only distributed to 2 consignees in TX; however recalling firm reported that product is then distributed U.S. nationwide to consumers via individuals or internet
New Kopi Jantan Tradisional Natural Herbs Coffee, packaged in 13 gram red packets, and each box contains 25 packets, Made in Malaysia, USA Distributor: Bestherbscoffee LLC (USA), Email: bestherbscoffee@yahoo.com
Marketed without an approved NDA/ANDA: presence of undeclared desmethyl carbodenafil and undeclared milk.
Super Panther 7K Capsules 1250 mg blend, a) 1 count blister cards shipped in boxes of 30 (UPC# 6015577513247); and b) 6 count bottles (UPC# 601577513209), Distributed by SX Power CO., Brooklyn, NY
Marketed without an Approved NDA/ANDA;FDA analysis found product to be tainted with sildendafil and tadalafil
X-Laser Laser Light Show projector models Aurora, Caliente Aurora, PSX-400, Mobile Beat Max, Mobile Beat Max MKII, X-Beam, Hawk 500    High-power laser light show projector.
Failure to comply with performance standard requirements (21 CFR 1040.10(f))when operated in the user accessible auto and music modes of operation
Distribution was made to distributors located in CA, FL, and RI.  There was no foreign/military/government distribution.
Firebird NXG Spinal Fixation System Decorticating Planer, Catalog #36-1334, non-sterile, Rx.     .A Decorticating Planer is used to decorticate bone surrounding the spherical head of an implanted bone screw in order to provide clearance to allow for proper seating of the modular body, as well as to provide full range of modular body angulation. It is placed axially over the spherical head of the bone screw and rotated clockwise and counterclockwise to achieve the needed decortication
The plastic core of the Decorticating Planer was found to be missing, which could result in scoring of the bone screw neck if used at or beyond a 23 degree angle.
Toshiba Medical Radrex - i Digital Radiography X-ray system    Radrex-i is intended for use in conjunction with the ceiling suspended tube support, high voltage generator, and bucky stand or bucky table incorporating a fixed or detachable (portable) flat panel detector for radiography of the head, chest, abdomen, spine, neck, and limbs. This system is used for image acquisition, image display and trans mission/ output of images to external devices.
which required a reboot and loss of the image.
Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K , Ref. 506-30.  The firm names on the label are Sekisui Diagnostics (UK) Limited, United Kingdom, and Sekisui Diagnostics P.E.I. Inc., Canada.  Used in laboratory testing.
Reagent carryover from Sekisui ACTH when utilized on the BEC AU 680 analyzer may lead to falsely elevated BEC Lipase recovery exceeding the total precision specification.
Vitamin A&D Ointment (petroleum 93.5%), Skin Protectant, NET Wt. 0.18 OZ (5g),  Manufactured for Medline Industries, Inc., Northfield, IL 60093 USA.  NDC: 53329-090-16
Labeling Mixup; the individual A&D ointment foil packets are incorrectly labeled as petroleum jelly. The boxes and outer case are correctly labeled as A&D ointment.
AMLODIPINE BESYLATE TABLET, USP, 10 mg, 1000 count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC Montvale, NJ 07645, NDC 67877-217-10
PRESENCE OF FOREIGN TABLETS/CAPSULES:  A 2.5 mg Amlodipine Besylate tablet was found co-mingled with 10 mg Amlodipine Besylate tablets in a bottle labeled as Amlodipine Besylate 10 mg.
Worldwide distribution. US distribution in the states of : FL & TX.  Austria, China,  France, Germany, Greece, Hungary, India, Italy, Panama, Philippines, Poland, Saudi Arabia, Serbia, South Africa, South Korea, Spain, United Arab Emirates, United Kingdom.
Skintact Electrode for Defibrillation, Pacing, Monitoring, Cardioversion.    Product Usage:  Multifunction electrode for external defibrillation, pacing, cardioversion, and monitoring. The device is non-sterile and for single use only.      Used with automated external defibrillators
Certain lots of the defibrillation electrodes model DF59N and DF59NC may have a delay in connecting or not connect at all with the defibrillator ZOLL AED PLUS. This may cause a situation in which a patient, who is in a life threatening condition and requires a defibrillation shock, cannot be treated in good time.
Worldwide - US Nationwide Distribution in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and WY  and the countries of   Australia, Taiwan, China, Taiwan, Hong Kong, Greece, United Kingdom, England, Netherlands, Luxembourg, Ireland, Italy, Germany, India, Japan, Korea, Singapore, Thailand, Vietnam, South Africa, and Turkey
Makoplasty Partial Knee Application (PKA)    Product Usage:  The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software define spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.
Software discrepancy of not showing all the EE constants, when the screen is filled.
Total Hip Application (THA)     Product Usage:  The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software define spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.
PF-Glutathione 200mg/ml, 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659  1 (877) BELLA.
G.A.C 25/100/250mg, 30 mL Vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
B-Complex, 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659,1 (877) BELLA.
BevaDex (bevacizumab) 0.06mL Prefilled 32 g (1.25mg/1mg)  Syringes, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659 (877) BELLA.
Bevacizumab Prefilled 30g and 31 gram 1.25mg/0.05mL Syringes, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
Lidocaine Ophthalmic Gel 3.5%, 15mL bottles, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659,1(877) BELLA.
Sodium Bicarbonate 8.4%, 10 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
Mannitol 20%, 10 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
Methylcobalamin 10mg, (1mg/ml), 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
MIC 25/50/50, 30mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
L-Glutamine 100mg, 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
Calcium chloride 10%, 10 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
Methylcobalamin 10mg, (10mg/ml), 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
Phenylephrine2.5%/Tropicamide 1% Ophthalmic Solution, 15mL bottle, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
Magnesium Chloride 200mg, 30m L vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
Fluorescein Sodium, 5mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
Paroxetine tablets USP, 30mg, 30-count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA, Inc., Pennington, NJ 08534, NDC 68382-099-06, UPC 3 6838209906 8
Presence of Foreign tablets/capsules: risperidone Tablets were found in bottle of paroxetine Tablets
Platelet products, stored at an unacceptable temperature, were distributed.
Worldwide Distribution: US (nationwide) to states of: GA, IL, IN, MA, NC & TX and to countries of: Austria, France, Germany, Hong Kong, Italy, Netherlands, Spain, Sweden, Switzerland, Thailand and United Kingdom.
eMAG System, Ref 418591    It is an In Vitro Diagnostic Medical device intended for the automated isolation (purification and concentration) of total nucleic acids (RNA/DNA) from biological specimens, with liquid and homogeneous properties (as part of their natural characteristics or after pre-treatment).
Some anomalies have been identified during manufacturing controls.
Ninjacof (Chlophedianol HCL 12.5 mg and Pyrilamine Maleate 12.5 mg) Oral Solution, 16 fl. oz. (473 mL), Cotton Candy Flavor,  Manufactured for: Centurion Labs, LLC Birmingham, AL 35243 --- NDC 23359-032-16
Microbial contamination of Non-sterile Products; potential B. cepacia contamination
Ninjacof-A (Acetaminophen 160 mg, Chlophedianol HCL 12.5 mg and Pyrilamine Maleate 12.5 mg) Oral Solution, 16 fl. oz. (473 mL), Cotton Candy Flavor,  Manufactured for: Centurion Labs, LLC Birmingham, AL 35243  --- NDC 23359-033-16
Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL (Cherry Flavored), 473 mL bottles, Rx only, Manufactured by: VistaPharm, Inc. Largo, FL 33771 ---- NDC 66689-023-16
Labeling: Not Elsewhere Classified; product is incorrectly labeled as Class III controlled substance instead of  Class II controlled substance
To distributors in KS, MS, HI, NC, AL, GA, IA and NJ.
Product was distributed without going through the retort step.
Domestic: Nationwide to USA    Foreign: None    VA/DOD: VA CMOP CHARLESTON 3725 RIVERS AVE N. CHARLESTON SC 29405-7038, Ph. 303-339-4305
Rugby Tri-vitamin Liquid, 1 2/3 oz (50 mL)
The distribution firms Leader Brand, Major Pharmaceuticals, and The Harvard Drug Group dba Rugby Laboratories are jointly initiating a voluntary recall of multiple supplements due to possible product contamination with B. cepacia, which may result in serious infections that could be life-threatening in patients with compromised immune systems and in patients with chronic lung conditions such as cystic fibrosis.
Rugby Tri-vitamin Liquid, 1 2/3 oz (50 mL),  UPC Number:0   05368 50180  0, All Unexpired Lots
Major CertaVite Liquid, 8 oz. (236 mL),  UPC Number:3   09045 02309  9, All Unexpired Lots
Major Ferrous Drops,1 2/3 oz (50 mL),  UPC Number:3   09046 27350  9, All Unexpired Lots
Rugby Polyvitamin Liquid with Iron, 1 2/3 oz (50 mL)
Rugby Polyvitamin Liquid with Iron, 1 2/3 oz (50 mL),  UPC Number: 0   05368 53080  0, All Unexpired Lots
Rugby Polyvitamin Liquid, 1 2/3 oz (50 mL)
Rugby Polyvitamin Liquid, 1 2/3 oz (50 mL),  UPC Number:0   05368 45080  1, All Unexpired Lots
Rugby Ferrous Sulfate Liquid One Pint, (473 mL)
Rugby Ferrous Sulfate Liquid,One Pint  (473 mL),  UPC Number:0   05360 65085  8, All Unexpired Lots
Major Poly-Vita  Drops with Iron, 1 2/3 oz (50 mL)
Major Poly-Vita  Drops with Iron,1 2/3 oz (50 mL),  UPC Number:3   09045 10050  9, All Unexpired Lots
Rugby Calcionate Syrup, One Pint  (473 mL)
UPC Number: 0   05362 77085  1, All Unexpired Lots
Rugby Liquid Vitamin C Supplement, 4 oz., 118 mL
Rugby Liquid Vitamin C Supplement, 4 oz., 118 mL, UPC Number: 0   05360 16097  0, All Unexpired Lots
Leader Liquid Vitamin D Supplement for Breastfed Infants, 1 T oz (50 mL)
Leader Liquid Vitamin D Supplement for Breastfed Infants, 1 T oz (50 mL),  UPC Number: 0   96295 12862  8, All Unexpired Lots
Major Tri-Vita Drops,1 2/3 oz (50 mL),  UPC Number: 3   09046 27450  6, All Unexpired Lots
Rugby Cerovite Liquid,  236ML, UPC Number: 00536-2790-59, All Unexpired Lots
Leader Liquid Multivitamin Supplement for Infants and Toddlers  , 1 2/3 oz (50 mL)
Leader Liquid Multivitamin  Supplement for Infants and Toddlers 1 2/3 oz (50 mL),  UPC Number: 096295128611, All Unexpired Lots
Major D-Vita Drops,1 2/3 oz (50 mL),  UPC Number:3   09046 27350  9, All Unexpired Lots
Rugby D 3 Vitamin Liquid, 400 IUI/1 mL,  1 and 2/3 oz., 50 mL
Rugby D 3 Vitamin Liquid, 400 IUI/1 mL, UPC Number: 0   05368 40080  6, All Unexpired Lots
Rugby Fer-iron Liquid,  1 and 2/3 oz., 50 mL
Rugby Fer-iron Liquid, 1 and 2/3 oz., 50 mL, UPC Number: 00536-0710-80, All Unexpired Lots
Major Poly-Vita  Drops, 1 2/3 oz (50 mL)
Major Poly-Vita  Drops,1 2/3  oz (50 mL),  UPC Number:3   09045 09950  6, All Unexpired Lots
Breaded Fish with Vera Cruz Sauce;  In 13.4 oz 3 compartment tray that has the fish, rice pilaf and green peas.  Item number KD-0003  No labeling on individual trays, only on out box of 4 meals per case.
Internal label verification found that the breading ingredients for the fish patty were not on the ingredient statement and that wheat not listed as an ingredient or allergen. It also did not declare the correct variety of fish
Doctor Manzanilla Cough & Cold (diphenhydramine hydrochloride and phenylephrine hydrochloride) Syrup, 12.5 mg and 5 mg in each 5 mL, 4 fl oz. (118 mL) bottle, Distributed by: Midvalley Pharmaceuticals, Raymondville, TX  78580, UPC 7 62558 00316 1.
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Doctor Manzanilla Allergy & Decongestant Relief  (diphenhydramine hydrochloride and phenylephrine hydrochloride) Syrup, 12.5 mg and 5 mg in each 5 mL, 4 fl oz. (118 mL) bottle, Distributed by: Midvalley Pharmaceuticals, Raymondville, TX  78580, UPC 7 62558 00204 1.
Nationwide Distribution to AR, AZ, CA, CT, FL, GA, IL, IN, KY, LA, MI, MN, NC, NH, NV, NY, OR, PA, SC, TN, TX, VA, and WI.
Cell Marque, SOX-10 (Polyclonal), 7 mL, REF PA0813, IVD, This antibody is intended for in vitro diagnostic (IVD) use. SOX-10 Rabbit Polyclonal Primary Antibody is intended for laboratory use in the detection of the SOX-10 protein in formalin-fixed, paraffin-embedded tissue stained in qualitative immunohistochemistry (IHC) testing..
A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.
Product Code PA0813, Lot No. 47800,  Exp. Date 09/24/2019
Cell Marque, PAX8 (MRQ-50 Mab.), 7 mL, REF PA0808, IVD, This antibody is intended for in vitro diagnostic (IVD) use. PAX-8 (MRQ-50) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the PAX-8 protein in formalin-fixed, paraffin-embedded tissue stained in qualitative immunohistochemistry (IHC) testing
Product Code PA0808, Lot No. 47795, Exp. Date 09/24/2019
Cell Marque, Napsin A (MRQ-60 Mab.), 7 mL, REF PA0805, IVD,   The antibody is intended for in vitro diagnostic (IVD) use. Napsin A (MRQ-60) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the Napsin A protein in formalin-fixed, paraffin-embedded tissue stained in qualitative immunohistochemistry (IHC) testing.
Product Code PA0805, Lot No. 46349, Exp. Date 06/11/2019
Cell Marque, MSH6 (44 Mab.), 7 mL, REF PA0804, IVD,   The antibody is intended for in vitro diagnostic (IVD) use. MSH6 is a mismatch repair gene which is deficient in a high proportion of patients with microsatellite instability (MSI-H). This finding is associated with the autosomal dominant condition known as Hereditary Non-Polyposis Colon Cancer (HNPCC).
Product Code PA0804, Lot No. 45973, Exp. Date 05/21/2019
Cell Marque, Microphthalmia Transcription Factor (MiTF) (C5/D5 Mab.), 7 mL, REF PA0803, IVD,   The antibody is intended for in vitro diagnostic (IVD) use. The Microphthalmia Transcription Factor (MiTF) (C5/D5) antibody is intended for qualified laboratories to qualitatively identify by light microscopy the presence of associated antigens in sections of formalin-fixed, paraffin-embedded tissue sections using IHC test methods.
Product Code PA0803, Lot No. 46524, Exp. Date 06/25/2019
Cell Marque, Glypican-3 (1G12 Mab), 7 mL, REF PA0800, IVD, The antibody is intended for in vitro diagnostic (IVD) use. Glypican-3 (1G12) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the Glypican-3 protein in formalin-fixed, paraffin-embedded tissue stained in qualitative immunohistochemistry (IHC) testing.
Product Code PA0800, Lot No. 46232, Exp. Date 06/04/2019
Cell Marque, Podoplanin (D2-40 Mab), 7 mL, REF PA0796,  IVD,   The antibody is intended for in vitro diagnostic (IVD) use. The Podoplanin (D2-40) antibody is intended for qualified laboratories to qualitatively identify by light microscopy the presence of associated antigens in sections of formalin-fixed, paraffin-embedded tissue sections using IHC test methods
Product Code PA0796, Lot No. 47793, Exp. Date 09/24/2019
Phentermine, USP Capsules, 15 mg, 30 count bottles, Rx only, Packaged By: Aidarex Pharmaceuticals, Corona, CA, MFG: KVK-TECH INC. Newtown. PA --- 33261-0361-30
Failed Impurities/Degradation Specification; out-of-specification results for individual unknown impurities at the 30 month Room Temperature Retained Sample stability test
Homestyle 9111 block checked.; Keep Frozen; Pizza Crusts; Tomanetti Food Products, 625 Allegheny Avenue, Oakmont, PA 15139 stamped with code: Manufactured date 7-17-2017
After the firm received a consumer complaint, Tomanetti Food Products initiated a recall due to small pieces of flexible plastic found in 12-in. pizza shells.
Blood components, not manufactured according to specifications, were distributed.
Wegmans Assorted Muffins 4-Pack-18 oz. (1 lb. 2 oz.) 510g  packaged in clear plastic shell.  UPC:    77890-22744    .
4-pack may contain banana nut muffin containing walnuts, allergen-walnuts not listed on the ingredient label
Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479
The firm received increased customer complaints for Missing Red Line, Patient Slow Flow, Solution Slow Flow, and Inadequate Drain alerts on certain lots of the AMIA Automated Peritoneal Dialysis Set with Cassette.