Recall Z-0484-2024
Atrium Medical Corporation · initiated September 29, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.
Codes / lots: UDI-DI: 00650862150360, lot ME234686, expiration date 2023-02-24.
Reason for recall
A sterilization nonconformance prematurely aged the product, resulting in an inaccurate labeled expiration date.
FDA-determined cause: Nonconforming Material/Component
Action taken
An Urgent Medical Device - Removal notice was sent via Fed-Ex on October 25, 2023. The letter advises customers to check for and remove from inventory Atrium Firm PVC Catheter 36 FR Straight, part number 15036, lot ME234686. Forward this information to all current and potential Atrium Firm PVC Thoracic Catheter 36FR Straight users within your hospital / facility, or to any customer product was further distributed to. Contact your local Atrium/Getinge Customer Service department at (603) 880-1433 (press option 1), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone)to request a return authorization (RMA) and shipping instructions to return any affected product.
Details
- Recall number
- Z-0484-2024
- Initiated
- September 29, 2023
- Posted by FDA
- December 2, 2023
- Product code
- GBZ – Catheter, Cholangiography
- Quantity
- 2460 units (246 cases, 10 units/case)
- Distribution
- US: AL, AZ, CA, FL, IA, IL, IN, MD, MI, MN, NJ, PA, TN & TX
- Recalling firm
- Atrium Medical Corporation, Merrimack, NH