American Contract Systems Hand Pack Convenience Kit Sterilization Failure
American Contract Systems is recalling Hand Pack convenience kits that may not be sterile due to insufficient aeration time during sterilization. Affected devices distributed in CA, KS, ME, MN, MO, NE, and SD may pose a safety risk.
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 a Class II FDA medical device recall involving a potential sterility compromise—a risk-of-harm hazard. No illnesses, injuries, or deaths have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported receive a score of 3 (High).
Plain-English summary
American Contract Systems, Inc. is recalling Hand Pack convenience kits (Lot 982241, UDI-DI 00191072203717, expiration date 1/18/2025) distributed nationwide in California, Kansas, Maine, Minnesota, Missouri, Nebraska, and South Dakota.
The kits were released with insufficient aeration time during the sterilization process, which may have compromised the sterility of devices sterilized in the same cycle or aeration chamber. Non-sterile medical devices can pose a risk of infection or other adverse health effects when used.
Consumers should stop using the recalled kits and contact the manufacturer for instructions on replacement or return of the product.
The recalled product
- Product
- American Contract Systems Hand Pack convenience kit
- Manufacturer
- American Contract Systems, Inc.
- Hazard
- sterility-compromise
- sterilization-failure
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 (3)
- UDI-DI 00191072203717
- Lot 982241
- Exp. Date 1/18/2025.
Distribution
Distributed nationwide across the United States.
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