Medical Convenience Kits Recalled Due to Unvalidated Re-sterilization
American Contract Systems Inc. is recalling 32,433 medical convenience kits (ENT and head/neck surgical kits) because they were re-sterilized with ethylene oxide gas without validation for multiple sterilization cycles, and safety and effectiveness cannot be confirmed.
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: FDA Class II medical device recall with unconfirmed product safety and effectiveness due to unvalidated re-sterilization. While no illnesses or injuries have been reported, compromised sterilization assurance poses a theoretical risk in sterile surgical products.
Plain-English summary
American Contract Systems Inc. is recalling 32,433 medical convenience kits distributed to healthcare facilities. The affected kits include RCEN25B (ENT SDSC) and RCHN27D (Head and Neck RCH) product lines.
The kits were re-gassed—re-sterilized using ethylene oxide (EO) gas—after a nonconformance occurred during the initial sterilization process. The manufacturer has not validated that these products remain safe and effective when exposed to multiple sterilization cycles. As a result, the quality, safety, and effectiveness of the recalled products cannot be confirmed.
The affected kits were distributed to healthcare facilities in South Dakota, Iowa, Minnesota, Washington, and Illinois. Healthcare providers who received these kits should stop using them immediately.
If your facility received these kits, do not use them. Contact American Contract Systems Inc. or your medical supply distributor for further instructions, replacements, or to arrange return of the affected products.
The recalled product
- Product
- Medical convenience kits Item Number/Description RCEN25B ENT SDSC 0246972 RCHN27D HEAD AND NECK RCH 0246951
- Manufacturer
- American Contract Systems Inc.
- Hazard
- inadequate-sterilization
- safety-unconfirmed
- unvalidated-reprocessing
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 (2)
- RCEN25B UDI-DI 191072225115 lot 8138311 bag serial number N/A
- then entire lot is affected
Distribution
Distributed nationwide across the United States.
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