Boston Scientific Target, Transend EX Soft Tip Guide Wire, .014in /205cm, UPN: M001468060, Catalog Number: 46-806, Bosto
FDA device recall Z-0122-2008 · posted 2007-12-05 · Terminated
Recall details
- Recalling firm
- Boston Scientific Target
- Reason for recall
- Mislabeling: Product is labeled with the wrong expiration date: 2009-12. The correct expiration date is 2008-12.
- Action taken
- Boston Scientific issued a letter to all consignees by mail on June 14, 2007, titled Urgent Medical Device Recall or Correction - Immediate Action Required. The letter describes that the expiration date is incorrect. Discontinue use of the product, segregate it, complete the Reply Verification Tracking Form and fax it to Boston Scientific. Call 888-272-1001 to obtain a Returned Goods Authorization (RGA) number.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DQX
- Quantity affected
- 40
- Distribution
- Nationwide.
- Date initiated
- 2007-06-14
- Date posted
- 2007-12-05
- Date terminated
- 2007-12-21
- Location
- Fremont, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SCIMED TRANSPORT STEERABLE GUIDE WIRE AND ACCESS. (K931584) | Scimed | 1993-07-01 |