Atlas FDA

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

FDA device recall Z-1189-03 · posted 2003-08-29 · Terminated

Recall details

Recalling firm
Boston Scientific Scimed
Reason for recall
Some of the recalled catheters may be in pouches with incomplete seals.
Action taken
Consignees were sent a recall letter dated August 1, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them.
Root cause
Other
Status
Terminated
Product code
74GBK
Quantity affected
160 catheters (32 boxes of 5 each)
Distribution
The product was shipped nationwide in the United States.
Date initiated
2003-08-01
Date posted
2003-08-29
Date terminated
2005-10-31
Location
Maple Grove, MN

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