Boston Scientific brand pull Gastro-dome (percutaneous endoscopic gastrostomy tubes) Kit, 20 Frl; catalog number 6838.
FDA device recall Z-0967-05 · posted 2005-07-07 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corp
- Reason for recall
- Two blades may be heat staked onto the stiletto instead of the expected one blade.
- Action taken
- Customers were notified by a recall letter dated 6/7/05 which instructed them to return any of the recalled products on hand.
- Root cause
- Other
- Status
- Terminated
- Product code
- KNT
- Distribution
- Nationwide and Panama.
- Date initiated
- 2005-06-02
- Date posted
- 2005-07-07
- Date terminated
- 2006-12-13
- Location
- Spencer, IN
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT (K031538) | Boston Scientific Corp | 2003-06-27 |