Recall Z-1483-2020— Deroyal Industries, Inc. Lafollette
Class II · Terminated
Class II FDA medical device recall by Deroyal Industries, Inc. Lafollette, initiated 2020-02-06, terminated 2021-02-11. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: The sterile packaging has the potential to be compromised..
- Recalling firm
- Deroyal Industries, Inc. Lafollette
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-02-06
- Terminated
- 2021-02-11
- Firm location
- La Follette, TN, United States
Product description
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.
Reason for recall
The sterile packaging has the potential to be compromised.
Data sourced from openFDA. This site is unofficial and independent of the FDA.