Boston Scientific Scimed Radius Monorail 4.0 mm x 31 mm Stent Systems, Catalog Number H74917485400
FDA device recall Z-0776-03 · posted 2003-04-22 · Terminated
Recall details
- Recalling firm
- Boston Scientific Scimed
- Reason for recall
- A component within the manifold of the stent delivery systems was found to have pyrogen levels above specification.
- Action taken
- Consignees were sent a recall letter dated March 17, 2003. The letter requested that consignees discontinue use of stents from the affected lots and return them.
- Root cause
- Other
- Status
- Terminated
- Product code
- MAF
- Quantity affected
- 1 Stent System
- Distribution
- Nationwide in the United States
- Date initiated
- 2003-03-17
- Date posted
- 2003-04-22
- Date terminated
- 2004-07-02
- Location
- Maple Grove, MN
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