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Recall Observatory FDA recall evidence

Device product

Halyard SUTURE PACK CABG. Cardiovascular Procedure Convenience Kit.

Z-1742-2025

March 31, 2025

Class II

Product summary

Firm
AVID Medical, Inc.
Event
Event 96731
Status
Ongoing
Classification
Class II
Quantity
60 units
Official record key
device-enforcement:Z-1742-2025

Official wording

Reason: An issue with a raw material used to coat some surgical needles that may result in diminished performance and/or removal of some silicone needle coating during use.

Code information: Model No. SILV800-01; UDI: 10809160450680; Lot Code: Lot: 1642454; Exp: 2/4/2028.

Distribution pattern: US Nationwide distribution in the states of IL & LA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    An issue with a raw material used to coat some surgical needles that may result in diminished performance and/or removal of some silicone needle coating during use.