Boston Scientific Scimed Express 2 Monorail 2.5 mm 12mm Coronary Stent System, Catalog Number H7493505012250
FDA device recall Z-0711-03 · posted 2003-04-09 · Terminated
Recall details
- Recalling firm
- Boston Scientific Scimed
- Reason for recall
- The product units in the recalled lot were in pouches which could have incomplete seals that could lead to compromised sterility.
- Action taken
- Consignees were sent a recall letter dated March 20, 2003. The letter requested that the consignees discontinue use of stents from the affected lot and return them.
- Root cause
- Other
- Status
- Terminated
- Product code
- MAF
- Quantity affected
- 31 stents
- Distribution
- The product was shipped to 18 hospitals located nationwide in the United States. There are no US Government or foreign accounts.
- Date initiated
- 2003-03-20
- Date posted
- 2003-04-09
- Date terminated
- 2004-07-02
- Location
- Maple Grove, MN
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