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Recall Observatory FDA recall evidence

Device 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.

Z-1483-2020

February 06, 2020

Class II

Product summary

Firm
Deroyal Industries, Inc. Lafollette
Event
Event 84943
Status
Terminated
Classification
Class II
Quantity
669 units
Official record key
device-enforcement:Z-1483-2020

Official wording

Reason: The sterile packaging has the potential to be compromised.

Code information: Catalog Number DP40K; Lot Numbers: 74F1802710, 74G1802678, 74H1800763, 74D1900657, 74C1900811, 74D1700564

Distribution pattern: International distribution of Kuwait City, Kuwait.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    sterile packaging has the potential to be compromised