ClearanceBrief
Recall Z-1189-03 ยท 74G

Boston Scientific Scimed

Boston Scientific Medi-Tech Imager II 5F Selective Angiographic Catheter

DateAug 29, 2003 (initiated Aug 1, 2003)
StatusTerminated
ReasonSome of the recalled catheters may be in pouches with incomplete seals.
Root causeOther
ActionConsignees were sent a recall letter dated August 1, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them.
Quantity160 catheters (32 boxes of 5 each)
DistributionThe product was shipped nationwide in the United States.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.