ClearanceBrief
Recall Z-0257-06 ยท GAD Retractor

Boston Scientific Corporation

TLC Self -Retaining Retractor System-Single Product Code: 820-175

DateDec 1, 2005 (initiated Oct 25, 2005)
StatusTerminated
ReasonSterility of device compromised due to breach in packaging
Root causeOther
ActionBoston Scientific initiated the recall on October 25, 2005 to accouunts requesting the return of the product and completion of the Reply Verification Tracking Form.
Quantity5185
DistributionNationwide
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.