Date Initiated by Firm | May 17, 2019 |
Create Date | June 16, 2019 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1832-2019 |
Recall Event ID |
82950 |
510(K)Number | K111825 K160176 |
Product Classification |
Staple, implantable - Product Code GDW
|
Product | SIGNIA TRI-STAPLE 2.0 30MM MEDIUM/ THICK RELOAD
, SIG30AMT |
Code Information |
N6E0033UX N6H0768UX N6H0772UX N6K0521UX N6K0522UX N6K0667UX N6K0668UX N6L0687UX N6M0399UX N7A0018UX N7A0213UX N7A0401UX N7A0837UX N7B0787UX N7C0238X N7C0470X N7E0496X N7E1088X N7F0670X N7H0962X N7J0370X N8A0188X N8B0057X N8B0483X N8B0940X N8D0365X N8D0649X N8E0092X N8E0213X N8E0516X N8E1178X N8F0483X N8F0819X N8F0974X N8J0440X N8L0589Y N8M0529Y N9A0050Y N9A0427Y |
Recalling Firm/ Manufacturer |
Covidien LLC 60 Middletown Ave North Haven CT 06473-3908
|
For Additional Information Contact | Customer Service 800-962-9888 |
Manufacturer Reason for Recall | The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis. |
FDA Determined Cause 2 | Process control |
Action | All consignees were notified by letter delivered via Federal Express and/or certified mail beginning May 17, 2019. The letter informs customers of the recall of specific item codes and production lots of Covidien Endo GIA Articulating Reloads with Tri-Staple Technology due to the potential for a device to be missing one of two pin components that maintain alignment of the device jaws. Through this notification customers are instructed to take the following actions:
" Immediately quarantine and discontinue use of the affected item codes and lots.
" Return affected product.
" Forward the information to anyone who they have distributed affected Covidien Endo GIA" Articulating Reloads with Tri-Staple Technology.
" Complete the Recalled Product Return Form.
If you have any questions regarding this communication, please contact your Medtronic representative or Customer Service at 800-962-9888, option 2. |
Quantity in Commerce | 3,113,280 |
Distribution | Nationwide domestic distribution, worldwide foreign distribution. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = GDW 510(K)s with Product Code = GDW
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