Endo GIA Auto Suture Universal Articulating Loading Unit for use in abdominal, gynecologic, pediatric and thoracic surge
FDA device recall Z-0636-2018 · posted 2018-02-16 · Terminated
Recall details
- Recalling firm
- Covidien LLC
- Reason for recall
- Potential for failure of the device safety interlock. The safety interlock prevents an empty single-use loading unit from being fired a second time.
- Action taken
- All consignees were notified via Federal Express or certified mail on September 13, 2017, and the letter informs customers of the potential for failure of the device safety interlock and the actions they should take. Customers are requested to acknowledge receipt and understanding of the Urgent Field Corrective Action Notice. All in control inventory and product returned from customers will be scrapped.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- GDW
- Quantity affected
- 3,816
- Distribution
- Nationally
- Date initiated
- 2017-09-13
- Date posted
- 2018-02-16
- Date terminated
- 2019-06-28
- Location
- North Haven, CT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ENDO GIA(TM) STAPLERS, DST SERIES(TM) GIA(TM) STAPLERS, DST SERIES(TM) TA(TM) STAPLERS (K111825) | Covidien, Formerly US Surgical A Divison of Tyco H | 2011-10-25 |