Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.
FDA device recall Z-0484-2024 · posted 2023-12-02 · Open, Classified
Recall details
- Recalling firm
- Atrium Medical Corporation
- Reason for recall
- A sterilization nonconformance prematurely aged the product, resulting in an inaccurate labeled expiration date.
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- GBZ
- Quantity affected
- 2460 units (246 cases, 10 units/case)
- Distribution
- US: AL, AZ, CA, FL, IA, IL, IN, MD, MI, MN, NJ, PA, TN & TX
- Date initiated
- 2023-09-29
- Date posted
- 2023-12-02
- Location
- Merrimack, NH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ATRIUM THORACIC CATHETER (K831931) | Atrium Medical Corp. | 1983-10-04 |