Recall Z-1270-2020 ยท DWS Instruments, Surgical, Cardiovascular
TELEFLEX MEDICAL INC
Teleflex Medical Disposable Aortic Punch, in the following sizes: a) 2.8 mm, REF DP-28K b) 3.6 mm, REF DP-36K c) 4.0 mm, REF DP-40K d) 4.4 mm, REF DP-44K e) 4.8 mm, REF DP-48K f) 5.2 mm, REF DP-52K g) 5.6 mm, REF DP-56K h) 6.0 mm, REF DP-60K i) 2.8 mm, REF MDP-28K j) 3.6 mm, REF MDP-36K k) 4.0 mm, REF MDP-40K l) 4.4 mm, REF MDP-44K m) 4.8 mm, REF MDP-48K n) 5.2 mm, REF MDP-52K o) 5.6 mm, REF MDP-5
| Date | Jan 27, 2020 (initiated Jan 13, 2020) |
| Status | Terminated |
| Reason | There is a potential for the device packaging to become compromised; thus, the sterility of the device cannot be guaranteed. |
| Root cause | Under Investigation by firm |
| Action | The firm initiated the recall by letter on 01/13/2020. The actions to be taking be the consignees are as follows: Check inventory. If affected stock is found, discontinue use immediately and quarantine. Complete the acknowledgement form as soon as possible indicating whether you do or do not have stock and fax it to 1-855-419-8507 or email to recalls@teleflex.com. A customer service representative will contact you with a Return Goods Authorization (RGA) number and provide instructions for the return of products. For additional questions, contact the local sales representative or Customer |
| Quantity | 587066 units |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.