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.
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: 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.
- Affected units
- 90
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
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.
See all 8 products in this recall →Related recalls
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