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

Hazard

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

Details from the source

Reason for recall: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. Distribution: US Nationwide distribution in the state of OH. Quantity: 303 kits 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

UPC codes

00191072215727, 00191072233332

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.