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American Contract Systems, Inc. recalls Custom procedural convenience kits and trays, general & plastic surgery, labeled as: a) BRACHY THERAPY PROCEDURE PAC,

Recalled February 7, 2024 · FDA recall Z-0825-2024 · American Contract Systems

Hazard
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. · FDA Class II
Units
7881 units
Sold at
US Nationwide distribution.

Description

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.

Product
Custom procedural convenience kits and trays, general & plastic surgery, labeled as: a) BRACHY THERAPY PROCEDURE PAC, kit number AGBR90E; b) BRACHY THERAPY PROCEDURE PAC, kit number AGBR90E; c) MINI MINOR AGH ASC PACK, kit number AGMM60M; d) OUTPATIENT PORT ACCESS KIT 307907, kit number AHPO55J; e) General Pack, kit number BBGP31C; f) FRACTURE TABLE PACK, kit number FDFT75N; g) Arthroscopy Pack, kit number HCAR04K; h) BARIATRIC PACK, kit number HGBA92F; i) LAPAROTOMY PACK, kit number HNLP12J; j) MIDLINE CHANGE KIT, kit number HSMD20E; k) Minor General, kit number JSMI10I; l) ENDO VASCULAR PACK, kit number LVEV61; m) MAJOR PACK, kit number LVMJ21; n) HEAD AND NECK PACK, kit number MMHN37F; o) KIT, MINOR U BAR, kit number MMNU34E; p) KIT, MAJOR UNIVERSAL, kit number MMUN28E; q) VAG PLASTY PACK, kit number OSVP16; r) DR L MAJOR, kit number SALM40H; s) DR L MAJOR, kit number SALM40I; t) MINOR BASIN SAH, kit number SAMB25E; u) MAJOR SAH, kit number SAMJ36G; v) MINOR PACK, kit number SMMN65; w) General Pack, kit number THGN59D; x) MINOR PACK, kit number TPMN15; y) MAJOR UNIVERSAL PACK, kit number TPUN48
Manufacturer(s)
American Contract Systems, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →

American Contract Systems, Inc. recalls Custom procedural convenience kits and trays, general & plastic surgery, labeled as: a) BRACHY THERAPY PROCEDURE PAC, | RecallWatchUSA