CLASS II Device recall · Reported 25 Mar 2020 · FDA Enforcement Report
Teleflex Pilling Aortic Punch Sterile recalled
Deroyal Industries Inc. Lafollette is recalling Teleflex Pilling Aortic Punch Sterile. The recall was initiated on 6 Feb 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1483-2020
- FDA event ID
- 84943
- Recalling firm
- Deroyal Industries Inc. Lafollette, La Follette, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Feb 2020
- FDA classified
- 13 Mar 2020
- Reported
- 25 Mar 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 6 Feb 2020 | Recall initiated by company | |
| 13 Mar 2020 | Classified by FDA | +36 days |
| 25 Mar 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The sterile packaging has the potential to be compromised.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
International distribution of Kuwait City, Kuwait.
Questions about this recall
Why was it recalled?
The sterile packaging has the potential to be compromised.
Which lots are affected?
Catalog Number DP40K; Lot Numbers: 74F1802710, 74G1802678, 74H1800763, 74D1900657, 74C1900811, 74D1700564
Where was it sold?
International distribution of Kuwait City, Kuwait.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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