Recall Z-0758-2021
Boston Scientific Corporation · initiated November 16, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Contour VL Variable Length Ureteral Stent Set, UPN M006180155090, M006180156090, M006180156180, M006180156190
Codes / lots: GTIN 08714729423768: Lots 25928323, 25928324. GTIN 08714729423829: Lots 25928325, 25928326, 25933063, 25933064, 25933065. GTIN 08714729772743: Lot 25965814. GTIN 08714729765837: Lot 25966020.
Reason for recall
Trace amounts of metallic debris were found on the stent related to the manufacturing process. The debris was confirmed to be particles of nickel.
FDA-determined cause: Process design
Action taken
On November 16, 2020, the firm distributed Urgent Medical Device Removal letters to affected customers. Customers were informed of the product issue and asked to take the following actions: - Verify whether you have any product from the affected lots/batches within your inventory - Immediately cease use or distribution of any remaining unused product from the affected lots/batches - Segregate affected material and return it to BSC in accordance with removal instructions included in the letter. - Distributors should forward the notification to their customers Your local Sales Representative can answer any questions that you may have regarding this notification.
Details
- Recall number
- Z-0758-2021
- Initiated
- November 16, 2020
- Product code
- FAD – Stent, Ureteral
- Quantity
- 458 units
- Distribution
- Distribution US nationwide and Japan.
- Recalling firm
- Boston Scientific Corporation, Marlborough, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0757-2021 Class II | Contour VL Variable Length Ureteral Stent, UPN M0061801550, M0061801560, M0061801570Trace amounts of metallic debris were found on the stent related to the manufacturing process. The debris… | 11/16/2020Open, Classified |