Boston Scientific Radial Jaw Large Capacity Biopsy Forceps with Needle, Sterile, 240 mm. Box of 20 UPN Number: M00513331
FDA device recall Z-0117-2008 · posted 2007-10-31 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Device lacked manufacturing finishing process resulting in endoscope damage.
- Action taken
- Boston Scientific notified accounts by letter on 8/28/07 by Federal Express Priority mail. Accounts are requested to remove product from inventory and return product.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FFF
- Quantity affected
- 640 boxes
- Distribution
- Worldwide, including USA, Sweden, and South Africa.
- Date initiated
- 2007-08-28
- Date posted
- 2007-10-31
- Date terminated
- 2008-07-10
- Location
- Marlborough, MA
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