Medical Procedure Kit Recalled Over Potential Sterilization Compromise
American Contract Systems is recalling Special Procedure Pack convenience kits due to insufficient aeration time during sterilization, which may have compromised sterility. Distributed in California, Kansas, Maine, Minnesota, Missouri, Nebraska, and South Dakota.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class II recall involving potential sterility compromise of medical devices. No illnesses or injuries reported in source text. Per rubric, this is a risk-of-harm product where injury has not yet been reported, resulting in High severity (score 3).
Plain-English summary
American Contract Systems, Inc. is recalling its Special Procedure Pack convenience kit (112 units) due to a sterilization issue. The kits were released after insufficient aeration time during the sterilization process, which may have compromised the sterility of the kits sterilized on the same cycle or in the same aeration chamber.
The recalled kits were distributed nationwide in California, Kansas, Maine, Minnesota, Missouri, Nebraska, and South Dakota. The affected products include Model No. SLSP77G (UDI-DI 00191072198730, Lot 981241, expiration 1/19/2025) and Model No. EJAG58A (UDI-DI 00191072190093, Lot 982241, expiration 1/18/2025).
Users should cease use of affected kits immediately. Contact American Contract Systems for guidance on replacement or return of recalled units. Healthcare providers or facilities that have received these kits should verify their product lot numbers and model numbers against the recall information and remove them from service.
The recalled product
- Product
- American Contract Systems Special Procedure Pack convenience kit
- Manufacturer
- American Contract Systems, Inc.
- Affected units
- 112
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 (8)
- (1) Model No SLSP77G
- UDI-DI 00191072198730
- Lot 981241
- Exp. Date 1/19/2025
- (2) Model No EJAG58A
- UDI-DI 00191072190093
- Lot 982241
- Exp. Date 1/18/2025.
Distribution
Part of a larger recall action
This product is one of 8 recalled by American Contract Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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