Boston Scientific Expect Endoscopic Ultrasound Aspiration Needle, 22GA (0.72 mm) sterile, UPN M00550011, 5 pack, 428 Tec
FDA device recall Z-0811-2011 · posted 2010-12-27 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- The firm has received a high number of complaints related to difficulty advancing and/or retracting the needle.
- Action taken
- "Urgent Medical Device Recall - Immediate Action Required" notification letters were sent via Federal Express Priority mail on October 20, 2010. The letters identified the affected product and stated the reason for the recall. The notification instructs the account to immediately discontinue use of, 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- FCG
- Quantity affected
- 567 all products.
- Distribution
- Worldwide Distribution -- US and Canada.
- Date initiated
- 2010-10-20
- Date posted
- 2010-12-27
- Date terminated
- 2011-08-03
- Location
- Marlborough, MA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RESOUND ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE (K100712) | Boston Scientific Corporation | 2010-03-30 |