Boston Scientific Profile Single-Use Pediatric Snare 11mm UPN Outer Box M00562531 Inner Pouch: M00562530 , The single-us
FDA device recall Z-1850-2012 · posted 2012-06-21 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Difficulty in extending snare loop from the catheter
- Action taken
- Boston Scientific issued an Urgent Medical Device Recall Action letter via Federal Express Priority mail on May 16, 2012. The notification instructs the account to check their inventory, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests the completion of a Reply Verification Tracking Form. Scan and fax to 508-683-5578. For questions regarding this recall call 508-683-8000.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FDI
- Quantity affected
- 2760 units
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of Canada, Australia, Austria, Belgium, France, GB, Germany, Italy, Netherlands, Qatar, Spain, Sweden, and Switzerland
- Date initiated
- 2012-05-16
- Date posted
- 2012-06-21
- Date terminated
- 2013-02-28
- Location
- Marlborough, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PROPOSED TRADEMAN MICROVASIVE POLYPECTOMY SNARES (K941750) | Boston Scientific Corp | 1994-11-01 |