FDA Recall
Terminated
Boston Scientific Medi-Tech Imager II 5F Selective Angiographic Catheter
Recall: Z-1189-03
·
Initiated August 1, 2003
Recall
- Recall Number
- Z-1189-03
- Event Number
- 27034
- FEI Number
- 3002095335
- Product Code
- 74GBK
- Status
- Terminated
- Root Cause
- Other
- Initiated
- August 1, 2003
- Posted
- August 29, 2003
- Terminated
- October 31, 2005
- Address
- Boston Scientific Scimed One Scimed Place Maple, Grove, MN, 55311-1566
Description
Boston Scientific Medi-Tech Imager II 5F Selective Angiographic Catheter
Reason
Some of the recalled catheters may be in pouches with incomplete seals.
Action
Consignees were sent a recall letter dated August 1, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them.
Distribution
The product was shipped nationwide in the United States.
Quantity
160 catheters (32 boxes of 5 each)