2022 Product Recalls
0 recalls issued in 2022.
Fentanyl Citrate, in 0.9% Sodium Chloride Injection, 2.5 mg per 250 mL, (10 mcg per mL), Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-327-02.
Lack of Assurance of Sterility
EPINEPHIrine in 0.9% Sodium Chloride Injection, 8 mg per 250 mL (32 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-077-01.
Lack of Assurance of Sterility
EPINEPHrine in 0.9% Sodium Chloride Injection, 16 mg per 250 mL (64 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-627-01.
Lack of Assurance of Sterility
EPINEPHrine, 2 mg per 250 mL (8 mcg per mL) in 0.9% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY, 12903, NDC 70324-027-01.
Lack of Assurance of Sterility
dilTIAZem HCl in 5% Dextrose Injection, 125 mg per 125 mL, (32 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-951-01.
Lack of Assurance of Sterility
EPINEPHIrine in 0.9% Sodium Chloride Injection, 4 mg per 250 mL (16 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-227-01.
Lack of Assurance of Sterility
Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, Manufactured for: Gilead Sciences, Inc., Foster City, CA 94404, NDC 61958-2901-2
Presence of Particulate Matter: investigation into a customer complaint confirmed the presence of glass particulates.
PHENYLephrine HCl, 50 mg per 250 mL, (200 mg per mL) in 0.9% Sodium Chloride Injection, Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-901-01.
Lack of Assurance of Sterility
EPINEPHIrine in 0.9% Sodium Chloride Injection, 5 mg per 250 mL (20 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-052-01.
Lack of Assurance of Sterility
Morphine Sulfate in 0.9% Sodium Chloride Injection, 100 mg per 100 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Avenue, Plattsburgh, NY, 12903, NDC 70324-427-02.
Lack of Assurance of Sterility
NOREPINEPHRINE in 5% Dextrose Injection, 8 mg per 250 mL (32 mg per mL) Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-476-01.
Lack of Assurance of Sterility
Tuna, raw sold at meat counter and wrapped in butcher paper at point of purchase.
Tuna tested above 50 ppm histamine.
Giant Eagle, Diced Green Peppers, 10 oz. poly bags and 22# cases, also poly bags and cartons, 12/10 oz. bags per case and bulk 22 lbs. bags
Frozen Food Development, Lancaster, PA is initiating a recall of Giant Eagle, Diced Green Peppers, 10 oz. poly bags and 22# cases (12/10 oz. bags per case) and bulk 22 lbs. bags because they tested positive for Listeria Monocytogenes.
Giant Eagle Diced Green Peppers, 10 oz. 283 g, Frozen bag, 12 packages per case , Best By 10/14/2023 .
Giant Eagle, Inc., Pittsburgh, PA has initiated a recall of Giant Eagle Diced Green Peppers, 10 oz. 283 g, Frozen bag, 12 packages per case, Best By 10/14/2023 because the product tested positive for Listeriosis Monocytogenes.
BUBS Naturals Fountain of Youth Formula; Collagen Protein; Support for Hair, Skin & Nails; Biotin, Antioxidant, Vitamin C; Maqui Berry Net Wt. 10.16 oz. (288 g)
Supplement contains undeclared milk from MCT oil powder ingredient.
The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range with an intended use of disinfecting surfaces.
Excessive ultraviolet-C radiation
DBB-06 Hemodialysis Delivery System
Device lacks premarket approval.
Nikkiso notified customers on about 11/24/2021, via letter titled MEDICAL DEVICE RECALL. Customers were instructed that the affected functions have been disabled on affected units and no actions need to be taken. Customers were asked to complete the provided response form and return it to the technical service when they visit each facility to complete the software update. Questions can be directed to the firm at at 901-310-1567 option 1, Monday Friday, 9:00am-5:00pm CST, or by email at CS@nikkisomedical.us
DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, Sterile
The firm identified a nonconformance in Lot 04882 involving the endcap being manufactured to a longer length than indicated in product specifications, introducing the risk of the +6 mm endcap not seating flush with the nail while inserting during a procedure.
The firm indicated that they will send recall notification to sales representatives via email or certified mail. Customers will be instructed to remove all +6 mm endcaps from stock and to return to the recalling firm with a return label that will be provided at a later date. Customers with questions are to contact the recalling firm at (678)235-3314.
Fuel Tubes May Crack and Leak Fuel
A high-pressure fuel leak in the presence of an ignition source can increase the risk of a fire.
Cummins dealers will install vibration isolators, and replace the fuel tubes as necessary, free of charge. Owner notification letters were mailed on March 8, 2022. Owners may contact Cummins customer service at 1-800-286-6467.
Invacare TDX SP2 with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) Models: TDX SP2: TDXSP2, TDXSP2-CG, TDXSP2X-CG, TDXSP2-MCG, TDXSP2X-MCG, TDXSP2V, TDXSP2V-HD, TDXSP2HD, TDXSP2HD-CG, TDXSP2HD-MCG
Power Wheelchairs with a LiNX Gyro component running firmware version 6.1.2 can experience a more aggressive deceleration rate than the programmed rate due to the system following the incorrect deceleration profile, resulting in potential injury
Invacare issued Urgent Medical Device Letter issued on 11/12/21 to consignees who received devices with LiNX Gyro modules containing firmware version 6.1.2. This letter also contains instructions for consignees who upgraded devices in the field to version 6.1.2. A Consumer Letter will be provided on the recall website for Providers to send to end users who are impacted. Letter states reason for recall, health risk and action to take: Visit www. Invacare.com/RC916 within five (5) business days of receiving this notice. Enter the requested identification information to access the list of power wheelchair serial numbers and/or LiNX Gyro Modules sold to you and instructions to conduct this field correction. You will be prompted to provide responses to information requested regarding this field correction and affected units. " The account number required to access your list of impacted devices appears directly at the end of your company name in the mailing address. For example, ABC COMPANY-XXXXX. " The mailing postal code will also be required to log into your account. 2. Stop using LiNX Gyro Module firmware version 6.1.2 on all power wheelchair programming tools and stored electronic media. 3. Immediately update any LiNX Access iOS and LiNX Access PC tools containing LiNX Gyro Module firmware version 6.1.2 to the latest LiNX Access iOS or LiNX Access PC tool version. 4. Locate the power wheelchairs with affected LiNX Gyro Modules per the date ranges above. 5. For power wheelchairs built prior to the date ranges above, review your customer records to identify whether you have installed LiNX firmware version 6.1.2 on any LiNX Gyro-equipped power wheelchairs since the January 14, 2021 release date of firmware version 6.1.2. Note: If you do not have record of the firmware version installed on the LiNX Gyro Modules you have purchased from Invacare, you must connect to the LiNX system on the wheelchair using the LiNX Access tool to determine the firmware version of the Gyro