FlexTray"Procedure Delivery System ENDOPATH; FBW67XL, FD064, FDB15, TGL45XL, XBB02B, XBB58S, XBB59S, XLB01B, XLB50S, XPD
FDA device recall Z-2164-2008 · posted 2008-08-25 · Terminated
Recall details
- Recalling firm
- Ethicon Endo-Surgery Inc
- Reason for recall
- The firm discovered a component production issue which may cause the cartridge to deploy an incomplete staple line.
- Action taken
- Firm issued an Urgent: Device Recall notification instructing the user to not use products from these lot numbers. Examine their inventory immediately to determine if they have affected product on hand and remove them from inventory. Complete the Business Reply Form and fax it back. To return affected product, copy the BRF, place in box with your product, and affix the pre-printed UPS shipping label.
- Root cause
- Other
- Status
- Terminated
- Product code
- FZT
- Quantity affected
- 863 pieces
- Distribution
- Worldwide Distribution --- including USA and countries of ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRAZIL, CAYMAN ISLANDS, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, EGYPT, EL SALVADOR, F
- Date initiated
- 2008-04-24
- Date posted
- 2008-08-25
- Date terminated
- 2012-04-03
- Location
- Cincinnati, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PROXIMATE AND ENDOPATH LINEAR CUTTERS AND STAPLERS (K020779) | Ethicon Endo-Surgery, Inc. | 2002-06-05 |