Medical Cath Lab Pack Recalled Due to Sterilization Assurance Failure
American Contract Systems is recalling Cath Lab Pack CECL02P medical kits because an inoperable chart recorder caused humidity readings to be out-of-specification, preventing confirmation that sterilization requirements were met.
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 FDA Class II medical device recall involves an inability to confirm that sterilization assurance requirements were met due to a manufacturing control failure. Sterilization is a critical safety requirement for medical devices used in invasive procedures. Under the severity rubric, products presenting a direct risk of harm score as High.
Plain-English summary
American Contract Systems, Inc. is recalling the Cath Lab Pack CECL02P medical convenience kit. During manufacturing, an inoperable chart recorder caused humidity readings to be out-of-specification in one of the controlled environment areas. As a result, the company is unable to confirm that product sterilization assurance requirements were met.
The recalled product lot is 2405102 with an expiration date of May 10, 2025 (UDI-DI 00191072206497). The kits were distributed nationwide in Missouri, Minnesota, Massachusetts, Ohio, and Nebraska.
Healthcare providers who have this product should review their inventory and contact American Contract Systems, Inc. for instructions on handling and replacement options.
The recalled product
- Product
- Cath Lab Pack, CECL02P; Medical convenience kit
- Manufacturer
- American Contract Systems, Inc.
- Hazard
- sterilization-failure
- infection-risk
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: 00191072206497
- Lot: 2405102
- Exp: 05/10/2025
Distribution
Distributed nationwide across the United States.
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