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Recall Observatory FDA recall evidence

Device product

PICC Insertion Tray, Product Code: AMS-7192CS-3 Convenience kit for the insertion of PICCs into the vascular system.

Z-1639-2018

February 28, 2018

Class II

Product summary

Firm
Vygon U.S.A.
Event
Event 79752
Status
Terminated
Classification
Class II
Quantity
16,520 total products
Official record key
device-enforcement:Z-1639-2018

Official wording

Reason: Potential friction holes may affect the sterility of the product.

Code information: Lot Numbers: 16I024D, 16H009D, 16I019D, 16J018D, 16L002D, 16L058D, 17B001D, 17B031D, 17C009D, 17C050D, 17F031D, 17F033D, 17H048D, 17F034D, 17H041D, UDI: 08498840009765

Distribution pattern: Nationwide Distribution to states of: AZ, UT, WI, NJ, CT, TX, PA, VA, MN, MA, MO, FL, and CA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential friction holes may affect the sterility of the product.