Teleflex Pilling Aortic Punch Recalled for Potential Sterile Packaging Compromise
Deroyal Industries is recalling 669 units of Teleflex Pilling Aortic Punches because the sterile packaging may be compromised, potentially affecting cardiovascular surgical procedures.
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 2/5 (Moderate).
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, and the source text describes a potential packaging compromise without reporting any specific illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Deroyal Industries, Inc. is recalling 669 units of Teleflex Pilling Aortic Punches, 4.0mm. These sterile, disposable, prescription-only devices are included as part of the Intl-Cardiac Surgery Kit and are used for cardiovascular surgical procedures. The recall is due to the potential for the sterile packaging to be compromised.
The affected products are identified by Catalog Number DP40K and specific lot numbers: 74F1802710, 74G1802678, 74H1800763, 74D1900657, 74C1900811, and 74D1700564. The distribution pattern for these units is listed as International distribution of Kuwait City, Kuwait.
Healthcare facilities and distributors should stop using the affected devices and contact the recalling firm for instructions on return or disposal. Patients who have had procedures using these devices should consult their healthcare provider if they have concerns regarding the integrity of the sterile packaging.
The recalled product
- Product
- Teleflex Pilling Aortic Punch, 4.0mm. Sterile, Rx Only, disposable. Included as part of Intl-Cardiac Surgery Kit - Product Usage: This device is used for cardiovascular surgical procedures.
- Manufacturer
- Deroyal Industries, Inc. Lafollette
- Hazard
- Affected units
- 669
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 (7)
- Catalog Number DP40K
- Lot Numbers: 74F1802710
- 74G1802678
- 74H1800763
- 74D1900657
- 74C1900811
- 74D1700564
Distribution
Distribution scope not specified by the agency.
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