medical Class II Updated 2025-03-26

American Contract Systems Inc recalls LAPAROSCOPY PACK, Model No. CALS41F, CALS41F-01, CALS41G

Recalled Product

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


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 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
View official government recall

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