PICC Custom Kit GENESIS MEDICAL CENTER, 4.5F Dual Lumen , Catalog #60M120522. UPN M00160M1205221. Firm on label: Boston
FDA device recall Z-1052-05 · posted 2005-07-28 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Lumens may have incorrect lumen size marked on them.
- Action taken
- Letters dated March 5, 2004 with instructions to return product to Boston Scientific.
- Root cause
- Other
- Status
- Terminated
- Product code
- LJS
- Quantity affected
- 44 kits
- Distribution
- Nationwide. Medical facilities in CA, GA, IA, IL, ME, MI, MO, NJ, OH, TN TX, UT, WI,
- Date initiated
- 2004-03-05
- Date posted
- 2005-07-28
- Date terminated
- 2006-02-06
- Location
- Natick, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CLAMPLESS VALVED CATHETER-PICC (CVC-PICC) (K963097) | Bmw Medical, Inc. | 1996-10-18 |