American Contract Systems Cataract Pack Kits Recalled Due to Insufficient Sterilization Aeration
American Contract Systems is recalling Cataract Pack convenience kits due to insufficient aeration time during sterilization. The affected units may not be properly sterilized.
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 an FDA Class II recall of surgical kits with a sterilization defect that creates a risk of patient harm through non-sterile equipment use. No injuries or illnesses have been reported, placing it in the 'risk-of-harm products' category.
Plain-English summary
American Contract Systems, Inc. is recalling Cataract Pack convenience kits because they were released with insufficient aeration time following sterilization. This affected the kits sterilized on the same cycle or in the same aeration chamber.
Inadequate aeration time after sterilization can compromise the sterility assurance of medical devices. This creates a potential risk to patients if non-sterile surgical kits are used during cataract procedures.
The recall affects Cataract Pack convenience kits distributed nationwide in California, Kansas, Maine, Minnesota, Missouri, Nebraska, and South Dakota. The affected lot is 988241 with an expiration date of January 12, 2025. The product identifier is UDI-DI 00191072188762.
Patients, healthcare providers, and facilities that have received these kits should stop use and contact American Contract Systems, Inc. for further instructions regarding return or replacement of affected units.
The recalled product
- Product
- American Contract Systems Cataract Pack convenience kit
- Manufacturer
- American Contract Systems, Inc.
- Hazard
- Affected units
- 3
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 00191072188762
- Lot 988241
- Exp. Date 1/12/2025.
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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