Recall Z-0003-2021
Covidien, LP · initiated August 12, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 3.5 mm, Item Code 030452 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Codes / lots: Lot Numbers: T0C085X T8B048X T8K049X T8L087X T9J072X T7H002X T8B049X T8K095X T9G027X T9J099X T7L026X T8E063X T8L084X T9H043X T9L073X T7L027X T8E064X T8L085X T9H115X T9M016X T8B014X T8E075X T8L086X T9H116X T9M111X T8B015X T8F074X
Reason for recall
The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.
FDA-determined cause: Under Investigation by firm
Action taken
Urgent Medical Device Recall notification letters dated 8/12/20 were sent to customers. Required Actions: 1.Please immediately quarantine and discontinue use of affected item codes with associated lot numbers listedon Attachment A. 2.Please return affected product as indicated below. All unused products from the affected item codes and associated lot numbers must be returned. 3.If you have distributed the Covidien Endo GIA" Auto Suture" universal articulating loading units listed on Attachment A, please promptly forward the information from this letter to those recipients. 4.Complete the Recalled Product Return Form even if you do not have inventory. We regret any inconvenience this may cause. We are committed to patient safety and appreciate your prompt attention to this matter. If you have any questions regarding this communication, please contact your Medtronic representative or Customer Service at 800-962-9888, option 2.
Details
- Recall number
- Z-0003-2021
- Initiated
- August 12, 2020
- Product code
- GDW – Staple, Implantable
- Quantity
- 900,007 total
- Distribution
- Worldwide distribution - US Nationwide and Global Distribution.
- Recalling firm
- Covidien, LP, North Haven, CT
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0001-2021 Class II | Endo GIA Auto Suture Gray Universal Articulating Loading Unit 30 mm - 2.0 mm, Item Code…The device staples may not properly form upon application preventing adequate hemostasis. Use of a product… | 08/12/2020Open, Classified |
| Z-0002-2021 Class II | Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 2.5 mm, Item Code…The device staples may not properly form upon application preventing adequate hemostasis. Use of a product… | 08/12/2020Open, Classified |
| Z-0004-2021 Class II | Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 2.0 mm, Item Code…The device staples may not properly form upon application preventing adequate hemostasis. Use of a product… | 08/12/2020Open, Classified |
| Z-0005-2021 Class II | Endo GIA Auto Suture Universal Loading Unit 45 mm - 2.5mm, Item Code 030454 - Product…The device staples may not properly form upon application preventing adequate hemostasis. Use of a product… | 08/12/2020Open, Classified |
| Z-0006-2021 Class II | Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 3.5 mm, Item Code…The device staples may not properly form upon application preventing adequate hemostasis. Use of a product… | 08/12/2020Open, Classified |
| Z-0007-2021 Class II | Endo GIA Auto Suture Universal Loading Unit, Item Code 030457 - Product Usage: The Endo…The device staples may not properly form upon application preventing adequate hemostasis. Use of a product… | 08/12/2020Open, Classified |
| Z-0008-2021 Class II | Endo GIA Auto Suture Universal Articulating Loading Unit 60 mm - 3.5 mm, Item Code…The device staples may not properly form upon application preventing adequate hemostasis. Use of a product… | 08/12/2020Open, Classified |
| Z-0009-2021 Class II | Covidien Best Practices Procedure Kits containing Auto Suture Endo GIA Universal Loading…The device staples may not properly form upon application preventing adequate hemostasis. Use of a product… | 08/12/2020Open, Classified |