Recall Z-0122-2008 ยท DQX Wire, Guide, Catheter
Boston Scientific Target
Boston Scientific Target, Transend EX Soft Tip Guide Wire, .014in /205cm, UPN: M001468060, Catalog Number: 46-806, Boston Scientific Target, Fremont, CA 94538
| Date | Dec 5, 2007 (initiated Jun 14, 2007) |
| Status | Terminated |
| Reason | Mislabeling: Product is labeled with the wrong expiration date: 2009-12. The correct expiration date is 2008-12. |
| Root cause | Process control |
| 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. |
| Quantity | 40 |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K931584 | SCIMED TRANSPORT STEERABLE GUIDE WIRE AND ACCESS. Scimed, Jul 1, 1993 |