Skip to content
Recall Observatory FDA recall evidence

Device product

LAPAROSCOPY PACK, Model No. CALS41F, CALS41F-01, CALS41G

Z-1331-2025

February 06, 2025

Class II

Product summary

Firm
American Contract Systems Inc
Event
Event 96343
Status
Ongoing
Classification
Class II
Quantity
303 kits
Official record key
device-enforcement:Z-1331-2025

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: 1. Model No. CALS41F UDI-DI 00191072215727 Tray Lots 962241 70-050280 70-050870 70-051556 2. Model No. CALS41F-01 UDI-DI 00191072215727 Tray Lot 70-052412 3. Model No. CALS41G UDI-DI 00191072233332 Tray Lot 70-053051

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.