Custom Procedural Convenience Kits Recalled for Sterilization Validation Failure
American Contract Systems is recalling 244 custom procedural kits (Baby PICC, Pediatric PICC, and PORT PACK) distributed nationwide. Components subjected to sterilization without proper validation documentation may have reduced functionality or elevated sterilization residuals.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall with no reported hospitalizations, illnesses, or injuries. The hazards are theoretical—components may lose functionality or drug efficacy due to improper sterilization validation—but represent a risk-of-harm scenario. Per the rubric, recalls with unconfirmed hazards and no reported clinical incidents rate as High (Score 3).
Plain-English summary
American Contract Systems, Inc. is recalling custom procedural convenience kits distributed nationwide: Baby PICC Kit (kit numbers UIBP90J and UIBP90K), PORT PACK (kit number UIPO82AB), and Pediatric PICC Kit (kit number UIPP76K). The recall affects 244 units total.
During an internal investigation, the company identified that components were added to ACS sterilization trays and subjected to the ACS sterilization process. No documentation existed confirming these components were assessed for suitability to elevated temperatures for an extended period and to the sterilization process itself.
As a result, the components may have experienced loss or lack of functionality, loss of drug efficacy if applicable, or higher than specified ethylene oxide sterilization residuals. These conditions could affect the safety and effectiveness of the affected procedural kits.
The recall involves specific lot numbers with expiration dates ranging from July 2023 through April 2024. This is classified as a Class II recall by the FDA.
The recalled product
- Product
- 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;
- Manufacturer
- American Contract Systems, Inc.
- Hazard
- functionality-loss
- drug-efficacy-loss
- eo-residual-contamination
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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