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.
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 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.
- Affected units
- 1
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
Part of a larger recall action
This product is one of 19 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 19 products in this recall →Related recalls
Same manufacturer · American Contract Systems, Inc.
See all →- SevereFDA Recalls Medical Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
- HighFDA Recalls Medical Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
- HighRecall of Medical Convenience Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
- ModerateAmerican Contract System Convenience Kits Recalled for Performance Failures
FDA (Devices) · 2026-09-02
- ModerateAmerican Contract Systems Recalls Convenience Kits with Non-Conforming Catheters
FDA (Devices) · 2026-09-02
Same hazard · sterilization failure
See all →- SevereSteris VERIFY Biological Indicator Recall Due to Spore Population Concerns
FDA (Devices) · 2026-10-14
- HighSteris VERIFY Dual Species Biological Indicator Recall for Spore Population Issues
FDA (Devices) · 2026-10-14
- SevereSteris VERIFY Biological Steam Test Pack Recalled for Spore Population Defect
FDA (Devices) · 2026-10-14
- SevereSteris VERIFY Biological/Integrator Challenge Pack Recall for Spore Population Defect
FDA (Devices) · 2026-10-14
- SevereSteris Recalls VERIFY Biological Steam Test Packs Due to Spore Population Concerns
FDA (Devices) · 2026-10-14
Similar recalls
- HighAmerican Contract Systems Cataract Pack Kits Recalled Due to Insufficient Sterilization Aeration
FDA (Devices) · 2024-08-14
- HighAmerican Contract Systems Hand Pack Convenience Kit Sterilization Failure
FDA (Devices) · 2024-08-14
- HighMedical Procedure Kit Recalled Over Potential Sterilization Compromise
FDA (Devices) · 2024-08-14
- ModerateACS Cath Lab Packs Sterilized with Excess Ethylene Oxide
FDA (Devices) · 2022-05-18
- HighSurgical Convenience Kits Recalled for Potential Sterilization Failure
FDA (Devices) · 2024-08-14
- HighBiopsy Drape Pack sterilization failure recall from American Contract Systems
FDA (Devices) · 2024-08-14