Recall Z-1269-2020
Teleflex Medical Inc · initiated January 13, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Pilling Aortic Punch, 4.0 mm Standard Tip, REF 353440
Codes / lots: Lot Number 74B1500674
Reason for recall
There is a potential for the device packaging to become compromised; thus, the sterility of the device cannot be guaranteed.
FDA-determined cause: Under Investigation by firm
Action taken
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 Service at 1-866-396-2111.
Details
- Recall number
- Z-1269-2020
- Initiated
- January 13, 2020
- Posted by FDA
- January 27, 2020
- Terminated
- November 24, 2021
- Product code
- DWS – Instruments, Surgical, Cardiovascular
- Quantity
- 1764 units
- Distribution
- Worldwide
- Recalling firm
- Teleflex Medical Inc, Morrisville, NC
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1270-2020 Class II | Teleflex Medical Disposable Aortic Punch, in the following sizes: a) 2.8 mm, REF DP-28K…There is a potential for the device packaging to become compromised; thus, the sterility of the device… | 01/13/2020Terminated |