Recall Z-1269-2020— TELEFLEX MEDICAL INC
Class II · Terminated
Class II FDA medical device recall by TELEFLEX MEDICAL INC, initiated 2020-01-13, terminated 2021-11-24. FDA's recall record names no specific 510(k) clearance for this event. Product: Pilling Aortic Punch, 4.0 mm Standard Tip, REF 353440. Reason: There is a potential for the device packaging to become compromised; thus, the sterility of the device cannot be guaranteed..
- Recalling firm
- TELEFLEX MEDICAL INC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-01-13
- Terminated
- 2021-11-24
- Firm location
- Morrisville, NC, United States
Product description
Pilling Aortic Punch, 4.0 mm Standard Tip, REF 353440
Reason for recall
There is a potential for the device packaging to become compromised; thus, the sterility of the device cannot be guaranteed.
Data sourced from openFDA. This site is unofficial and independent of the FDA.