FDA Recall
Terminated
Boston Scientific Target, Transend EX Soft Tip Guide Wire, .014in /205cm, UPN: M001468060, Catalog Number: 46-806, Boston Scientific Target, Fremont, CA 94538
Recall: Z-0122-2008
·
Initiated June 14, 2007
Recall
- Recall Number
- Z-0122-2008
- Event Number
- 38310
- Firm
- Boston Scientific Target
- FEI Number
- 2939204
- Product Code
- DQX
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- June 14, 2007
- Posted
- December 5, 2007
- Terminated
- December 21, 2007
- Address
- 47900 Bayside Pkwy, Fremont, CA, 94538-6515
Description
Boston Scientific Target, Transend EX Soft Tip Guide Wire, .014in /205cm, UPN: M001468060, Catalog Number: 46-806, Boston Scientific Target, Fremont, CA 94538
Reason
Mislabeling: Product is labeled with the wrong expiration date: 2009-12. The correct expiration date is 2008-12.
Action
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.
Distribution
Nationwide.
Quantity
40