Surgical Convenience Kits Recalled for Potential Sterilization Failure
American Contract Systems is recalling three surgical convenience kits due to potential sterilization failure from insufficient aeration time during processing.
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 sterilization failure of surgical medical devices. The hazard is theoretical (compromised sterility with no confirmed illnesses or injuries reported), which per the severity rubric constitutes a risk-of-harm product where injury has not yet been reported.
Plain-English summary
American Contract Systems, Inc. is recalling three surgical convenience kits: the Extremity convenience kit, Hand Pack convenience kit, and Total Knee Pack convenience kit. A total of 15 kits have been affected.
The kits were released with insufficient aeration time during the sterilization process, which may have compromised the sterility of affected units processed on the same sterilization cycle or in the same aeration chamber. Surgical instruments and kits that are not properly sterilized pose a risk of infection when used in medical procedures.
The affected products were distributed nationwide to healthcare facilities in California, Kansas, Maine, Minnesota, Missouri, Nebraska, and South Dakota. Healthcare providers and patients who may have received these kits should contact American Contract Systems, Inc. or their healthcare facility for further guidance.
Specific lot numbers and model information for the recalled products are available through the FDA recall notification. The FDA is monitoring this recall and the manufacturer's response.
The recalled product
- Product
- American Contract Systems Extremity convenience kit, American Contract Systems Hand Pack convenience kit, and American Contract Systems Total Knee Pack convenience kit
- Manufacturer
- American Contract Systems, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 15
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 (12)
- (1) Model No ALEX17A
- UDI-DI 00191072201546
- Lot 983241
- Exp. Date 1/17/2025
- (2) Model No AKHD97A
- UDI-DI 00191072201126
- Lot 988241
- Exp. Date 1/12/2025
- (3) Model No CETJ13O
- UDI-DI 00191072202017
- Lot 989241
- Exp. Date 1/11/2025.
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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