Z-1483-2020 Class II Terminated
FDA device recall Z-1483-2020 was initiated by Deroyal Industries, Inc. Lafollette on February 6, 2020 and is designated Class II. Reason for recall: The sterile packaging has the potential to be compromised. The recall status is terminated (terminated February 11, 2021). Affected quantity: 669 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 25, 2020
- Initiation Date
- February 6, 2020
- Termination Date
- February 11, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 669 units
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.
Distribution Pattern
International distribution of Kuwait City, Kuwait.
Code Information
Catalog Number DP40K; Lot Numbers: 74F1802710, 74G1802678, 74H1800763, 74D1900657, 74C1900811, 74D1700564