Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 1 cm Tip and 20 mm Balloon, Catalog N
FDA device recall Z-0032-04 · posted 2003-10-15 · Terminated
Recall details
- Recalling firm
- Boston Scientific Scimed
- Reason for recall
- Some of the recalled catheters have a component that has levels of pyrogens above specification.
- Action taken
- Consignees were sent a recall letter dated August 20, 2003. The letter requested that consignees discontinue use of the catheters from the affected lots and return them.
- Root cause
- Other
- Status
- Terminated
- Product code
- LOX
- Quantity affected
- 2 catheters
- Distribution
- The recalled products were distributed to consignees located nationwide in the United States.
- Date initiated
- 2003-08-20
- Date posted
- 2003-10-15
- Date terminated
- 2005-10-24
- Location
- Maple Grove, MN
Monitor recalls programmatically
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