Teleflex Medical Recalls Disposable Aortic Punches Due to Packaging Compromise
Teleflex Medical is recalling 587,066 units of Disposable Aortic Punches because packaging may be compromised, potentially affecting device sterility.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Teleflex Medical Inc. is recalling 587,066 units of its Disposable Aortic Punches, available in various sizes and reference codes (DP and MDP series). The recall is due to a potential for the device packaging to become compromised, which means the sterility of the device cannot be guaranteed.
The affected products were distributed worldwide. The recall covers specific lot numbers for each size and reference code, ranging from 2.8 mm to 6.0 mm.
Healthcare providers and consumers should stop using these devices and contact Teleflex Medical for further instructions or replacement. The FDA has classified this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- 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.
- Manufacturer
- TELEFLEX MEDICAL INC
- Affected units
- 587,066
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- a) Teleflex Medical Disposable Aortic Punch
- 2.8 mm
- REF DP-28K Lot Numbers: 74A1501140
- 74B1602364
- 74E1700597
- 74G1602599
- 74H1900357
- 74L1501549
- 74A1601253
- 74B1900832
- 74E1800886
- 74G1700636
- 74J1501218
- 74L1501977
- 74A1601254
- 74C1501113
- 74E1802643
- 74G1700637
- 74J1501754
- 74L1501978
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by TELEFLEX MEDICAL INC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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