Reported Feb 26, 2020 · Terminated
Teleflex Medical Disposable Aortic Punch, in the following sizes
Teleflex Medical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: TELEFLEX MEDICAL INC · 3015 Carrington Mill Blvd · Morrisville, NC · 27560-5437
Is this the product you have?
Teleflex Medical Disposable Aortic Punch, in the following sizes
16 of 16 products
| Model / number | Product as published |
|---|---|
DP-28K | 2.8 mm |
DP-36K | 3.6 mm |
DP-40K | 4.0 mm |
DP-44K | 4.4 mm |
DP-48K | 4.8 mm |
DP-52K | 5.2 mm |
DP-56K | 5.6 mm |
DP-60K | 6.0 mm |
MDP-28K | 2.8 mm |
MDP-36K | 3.6 mm |
MDP-40K | 4.0 mm |
MDP-44K | 4.4 mm |
MDP-48K | 4.8 mm |
MDP-52K | 5.2 mm |
MDP-56K | 5.6 mm |
MDP-60K | 6.0 mm |
- Amount recalled
- 587066 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was recalled
There is a potential for the device packaging to become compromised; thus, the sterility of the device cannot be guaranteed.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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