Boston Scientific Radial Jaw 4 Large Capacity w/Needle Biopsy Forceps Inner Pouch 240cm, Box 20 UPN/Catalog Number: M005
FDA device recall Z-1772-2010 · posted 2010-06-04 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Clevis may detach from the coil preventing the device to open and/or close. Delays in the procedure may result.
- Action taken
- Boston Scientific issued Recall notification letters via Federal Express Priority mail on May 6, 2010. The notification instructs the account to check their inventory, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests the completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product from their inventory. In the letter, customers with questions are provided with a phone and email at the firm to contact.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FCL
- Quantity affected
- 320 units
- Distribution
- Nationwide; Panama.
- Date initiated
- 2010-05-06
- Date posted
- 2010-06-04
- Date terminated
- 2011-09-20
- Location
- Marlborough, MA
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