Teleflex Recalls Pilling Aortic Punch Due to Packaging Compromise
Teleflex Medical Inc. is recalling 1,764 Pilling Aortic Punch devices because packaging defects may compromise sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where sterility cannot be guaranteed due to packaging compromise, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Teleflex Medical Inc. is recalling 1,764 units of the Pilling Aortic Punch, 4.0 mm Standard Tip (REF 353440). The recall is limited to Lot Number 74B1500674, which was distributed worldwide.
The recall was initiated because there is a potential for the device packaging to become compromised. This defect means that the sterility of the device cannot be guaranteed.
Healthcare facilities and distributors should stop using the affected devices and contact Teleflex Medical Inc. for further instructions on returns or replacements.
The recalled product
- Product
- Pilling Aortic Punch, 4.0 mm Standard Tip, REF 353440
- Manufacturer
- TELEFLEX MEDICAL INC
- Affected units
- 1,764
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 (1)
- Lot Number 74B1500674
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.
See all 2 products in this recall →Related recalls
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