2022 Product Recalls

Incorrect Rearview Camera/FMVSS 111

An inoperative rearview camera can reduce the driver's rear visibility, increasing the risk of a crash.

Dealers will supply a digital rearview camera, free of charge. Owner notification letters were mailed February 7, 2023. Owners may contact FCA US, LLC customer service at 1-800-853-1403. FCA US, LLC's number for this recall is ZC5

Samsung Top-Load Washing Machines Recalled for Fire Hazard

The washing machines can short-circuit and overheat, posing a fire hazard.

Consumers should immediately check whether their washer's software has been updated to prevent the hazard; and, if not, consumers should immediately stop using the washer until the software is updated. Instructions on how to check whether a washer's software has been updated can be found here https://www.samsung.com/us/support/tlw-sw-update. All Wi-Fi equipped washers that are plugged into a power source and actively connected to the internet will automatically download the free software repair over-the-air when they are connected to the internet. Consumers who have not connected their Wi-Fi equipped washer to the internet should contact Samsung for instructions on how to download the software repair. Consumers whose washer does not have Wi-Fi capability or who otherwise wish to receive a free software repair without connecting to the internet, should immediately stop using the washer and contact Samsung directly for a free dongle to plug in and download the free software repair.

Home Bed Rails Recalled for Entrapment Hazard

When the bedrail is attached, users can become entrapped within the bed rail or between the bed rail and the side of the mattress. This poses a serious entrapment hazard and risk of death by asphyxiation.

Consumers should immediately stop using the recalled bed rails and contact Nova Medical Products for a free repair or replacement, depending on the model. Nova Medical Products expects the remedy to be available beginning in March 2023.

Nomad Battery-Powered Tankless Diving Systems Recalled for Drowning Hazard

The compressor head of the tankless diving system can fracture while in use resulting in restricted air flow, posing a drowning hazard for divers.

Consumers should immediately stop using the recalled Nomad tankless diving systems and contact BLU3 to schedule a free repair at an approved service center. BLU3 is contacting all known purchasers directly. The repair cannot be performed by the consumer.

Pillowfort™ Weighted Blankets Recalled for Entrapment Hazard

A young child can become entrapped by unzipping and entering the blanket, posing a risk of death by asphyxiation.

CPSC and Target are urging consumers to stop using the recalled weighted blankets immediately and contact Target for a refund. Target is also contacting all known purchasers directly to arrange returns. The consumer will receive a refund of $40 in the form of a credit for use at Target stores or online at www.target.com, or the amount on the purchase receipt if higher.

Pacific Igniter and Pacific Bubble Pop 20" kids' bicycl Recalled for Fall Hazard

The bicycle's handlebar can become loose during use, posing a fall hazard.

Consumers should immediately stop riding the recalled bicycles and contact Pacific Cycle to receive a free repair kit, which will contain a bolt, nut, washer and grease packet with instructions to apply grease to the bolt.

GASGAS Off-Road Motorcycles Recalled for Poisoning Hazard

An incorrectly programmed CDI box can lead to engine failure, posing crash and injury hazards.

Consumers should immediately stop riding the recalled motorcycles and contact an authorized GASGAS Motorcycle dealer to schedule a free repair, which involves replacing the CDI box. KTM is contacting all known purchasers directly.

Morasch Meats Inc. Recalls Raw Frozen Diced Beef Products Due to Possible E. Coli O157:H7 Contamination

Product Contamination

JUDKINS PACK

Component Part Number: 19537LBL (LBL, SHEET OF 39, ASSORTED, STDSZ, MULTI W/BLK INK, WATERPROOF) is being reported as intermittently mixed with an incorrect medication label sheet throughout the specific Presource kit SANHDJTVCF Judkins Pack lot # 525067.

The notice "Presource Kits Containing an Incorrect Medication Label Sheet" and reply form dated 02/11/2021 were sent to the customer. For questions, requiring additional labels, or desire special assistance relating to this notice, contact Cardinal Health Quality Systems at 800.292.9332.

Driver's Side Air Bag Inflator May Explode

An inflator explosion may result in sharp metal fragments striking the driver or other occupants resulting in serious injury or death.

Dealers will replace the driver's side air bag, free of charge. Owners notification letters were mailed October 26, 2023. Owners may contact Volkswagen's customer service at 1-800-893-5298. Volkswagen's number for this recall is 69EM.

ProSirona, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl. oz. (3.5 g) bottles, Dist. by: Endometriosis Assoc. Inc. (International), Mfg. by Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233-712-01.

cGMP Deviations

FentaNYL Citrate 2.5 mg/50 mL (50mcg/ml) Injection Solution, Preservative Free, Single Use 50 ml Cassette, Rx Only, Repackaged by OurPharma, LLC. 2512 S. City Lake Rd. Fayetteville, AR 72701, 1-833-290-2654, NDC 73013-001-01

Underfilled units.

Lacosamide Oral Solution, USP, CV, 10mg/mL, packaged in 200 mL bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Manufactured By: HETERO LABS LIMITED, Jeedimetla, Hyderabad - 500 055, India, NDC 31722-627-26

Failed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid content

8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx Only, Mfd for: Civica, Inc. Lehi, Utah 84043, Mfd by: Exela Pharma Sciences, LLC, Lenoir, NC 28645, Carton NDC 72572-740-20, vial NDC 72572-740-1.

Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.

Neuroquell Plus, Advanced Formula, A Homeopathic Drug, Calendula Oil packaged in 0.22 Fl. oz. (6.6 mL) bottles, Mfg. for/Dist. By Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233712-01.

cGMP Deviations

8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx only, Manufactured and Distributed by: Exela Pharma Sciences, LLC Lenoir, NC 28645. Carton NDC 51754-5001-5, vial NDC 51754-5001-1.

Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.

Menastil, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl. oz. (3.5 g) bottles, Mfg. for/Dist. By Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233-711-01.

cGMP Deviations

Iohexol (300 mg Iodine/mL), 2.4 g Iodine/8 ml, Total Volume 8 ml in 10 ml syringe, 5-count syringes packaged in a bag labeled as Omnipaque (iohexol) 300 mg I/mL, 2.4g Iodine/8 mL in a 10 mL syringe, Compounded with GE Healthcare product, Each mL contains (647 mg) of iohexol as 300 mg of organically bound iodine, 1.21 mg tromethamine, and 0.1 mg edetate calcium disodium, For Injection or oral use; Rx Only, BayCare Central Pharmacy, 7802 Telecom Parkway, Temple Terrace, FL 33637.

Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained product 350 mg iodine/mL

Neuroquell, A Homeopathic Drug, Calendula Oil, packaged in1/8 Fl. oz. (3.5 g) bottles, Mfg. for/Dist. By Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233712-01.

cGMP Deviations

PROCEED Surgical Mesh Hernia Mesh Oval, 15 cm x 20 cm

The firm is recalling the PROCEED Surgical Mesh device, because it is a sterile device, and a customer found a hair inside of the primary packaging of a single unit.

Note: This recall is specific to this single lot of PROCEED Surgical Mesh. Health care practitioners who have treated patients using this product should follow those patients post-operatively in the usual manner with no additional action required. Product subject to the recall in your inventory can be identified by the product code information described in the above table. all unused PROCEED Surgical Mesh subject to this recall are required to be returned. Please utilize attachment 1 for assistance in identifying the product lots subject to this recall. ACTION REQUIRED: 1. Examine your inventory immediately to determine if you have product subject to this recall on hand and quarantine such product(s). 2. Remove the product subject to this recall and communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. 3. If any product subject to this recall has been forwarded to another facility, contact that facility to arrange return. Please consider including a copy of this recall letter when communicating. 4. Complete the Business Reply Form (Attachment 2) confirming receipt of this notice and return to Ethicon sales representative or distributor by [INSERT DATE]. Please return the Business Reply Form even if you do not have products subject to this recall. 5. Follow instructions in the letter and immediately return unused impacted PROCEED Surgical Mesh subject to this recall to Ethicon sales representative or distributor. To receive credit reimbursement, customers must return product subject to this recall. Any non-affected product and any product returned after the date specified will not receive credit. 6. Keep this notice visibly posted for awareness until all product subject to this recall has been returned to Ethicon Korea. While processing your returns, please maintain a copy of this notice with the product subject to this recall and keep a copy for your re