Medical Device Kit Recall: Sterilization Assurance Cannot Be Confirmed
American Contract Systems is recalling 60 Shoulder SESH18I medical convenience kits nationwide due to equipment failure that resulted in out-of-specification humidity readings, preventing sterilization assurance confirmation.
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 where sterilization assurance requirements cannot be confirmed due to inoperable environmental monitoring equipment. No illnesses or injuries reported. Meets High severity as a risk-of-harm product with no documented actual harm.
Plain-English summary
American Contract Systems, Inc. is recalling 60 units of the Shoulder SESH18I medical convenience kit (UDI-DI: 00191072198532, Lot: 2405112, Expiration: 05/11/2025) distributed nationwide in Missouri, Minnesota, Massachusetts, Ohio, and Nebraska.
An inoperable chart recorder in a controlled environment area resulted in humidity readings that fell out of specification. Due to this equipment failure, American Contract Systems, Inc. cannot confirm that sterilization assurance requirements were met for the affected kits.
Individuals and facilities who may have received these kits should be aware of this recall.
The recalled product
- Product
- Shoulder, SESH18I; Medical convenience kit
- Manufacturer
- American Contract Systems, Inc.
- Hazard
- sterilization-assurance-failure
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: 00191072198532
- Lot: 2405112
- Exp: 05/11/2025
Distribution
Distributed nationwide across the United States.
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