Recall Z-0830-2024— American Contract Systems, Inc.

Class II FDA medical device recall by American Contract Systems, Inc., initiated 2023-11-29. FDA's recall record names no specific 510(k) clearance for this event. Product: Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) C-SECTION PACK, kit number FDCS01AA; b) C-SECTION PACK, kit number FDCS01AB; c) C-SECTION STERILE PACK, kit number HGCS68J; d) C-SECTION PACK, kit number HICS50H; e) C-SECTION PPS, kit number LLCI66; f) C-Section drape Pack, kit number RBCS12R; g) C-Section, kit number THCS49B; h) C-SECTION PACK (PS 020632), kit number UICS50AG;. Reason: During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the "piggybacked" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the piggybacked components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals..

Recalling firm

American Contract Systems, Inc.

Classification

Class II

Status

Ongoing

Initiated

2023-11-29

Firm location

Temple Terrace, FL, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.