CP STENT (Cheatham Platinum), a prescription device, composed of 90% platinum/10% iridium wire arranged in laser welded
FDA device recall Z-0983-03 · posted 2003-07-08 · Terminated
Recall details
- Recalling firm
- Numed Inc
- Reason for recall
- Lacks a PMA or 510k.
- Action taken
- Recall Letters were sent to doctors dated 6/26/03 requesting return of the stents.
- Root cause
- Other
- Status
- Terminated
- Product code
- MAF
- Quantity affected
- 169 units
- Distribution
- The stents were shipped to individual doctors in 29 hospitals in the U.S.
- Date initiated
- 2003-06-26
- Date posted
- 2003-07-08
- Date terminated
- 2004-06-09
- Location
- Hopkinton, NY
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