Custom procedural convenience kits and trays, general hospital use, labeled as: a) Baby PICC K...
FDA Recall #Z-0826-2024 — Class II — November 29, 2023
Product Description
Custom procedural convenience kits and trays, general hospital use, labeled as: a) Baby PICC Kit, kit number UIBP90J; b) Baby PICC Kit, kit number UIBP90K; c) PORT PACK (PS 058330), kit number UIPO82AB; d) Pediatric PICC Kit, kit number UIPP76K;
Reason for Recall
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. — Temple Terrace, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
244 units
Distribution
US Nationwide distribution.
Code Information
a) UIBP90J, UDI/DI 00191072117038, Lot Numbers: 996231, exp. 1/4/2024; b) UIBP90K, UDI/DI 00191072189356, Lot Numbers: 911231, exp. 7/26/2023; c) UIPO82AB, UDI/DI 00191072172006, Lot Numbers: 727221, exp. 9/30/2023; 680221, exp. 11/16/2023; d) UIPP76K, UDI/DI 00191072142849, Lot Numbers: 637221, exp. 12/29/2023; 976231, exp. 1/24/2024; 898231, exp. 4/12/2024
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated