Boston Scientific Target, Transend EX Soft Tip Guide Wire, .014in /205cm, UPN: M001468060, Catalog Number: 46-806, Boston Scientific Target, Fremont, CA 94538
FDA Recall Z-0122-2008 · Posted 2007-12-05
Recalling FirmBoston Scientific Target
Recall StatusTerminated
Product CodeDQX
Date Initiated2007-06-14
Date Terminated2007-12-21
Product Quantity40
Reason for Recall
Mislabeling: Product is labeled with the wrong expiration date: 2009-12. The correct expiration date is 2008-12.
Firm 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.
Root Cause
Process control
Distribution Pattern
Nationwide.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.