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Recall Observatory FDA recall evidence

Device product

LAPAROSCOPY PACK , Model No SFLA02A SFLA02B

Z-1352-2025

February 06, 2025

Class II

Product summary

Firm
American Contract Systems Inc
Event
Event 96343
Status
Ongoing
Classification
Class II
Quantity
237 kits
Official record key
device-enforcement:Z-1352-2025

Official wording

Reason: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.

Code information: UDI-DI 00191072167491 00191072218698 Lots 971241 947241 926241 894241 70-051029 70-051995 70-052417 70-052771

Distribution pattern: US Nationwide distribution in the state of OH.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.