Day Surgery General Pack medical kit recalled for sterilization concern
American Contract Systems recalled 280 units of its Day Surgery General Pack due to humidity control failures that prevent confirmation of adequate sterilization.
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 unconfirmed sterilization of surgical instruments due to environmental control failures, representing a risk-of-harm scenario. No illnesses or injuries have been reported, placing this at the high-risk level per the rubric.
Plain-English summary
American Contract Systems, Inc. recalled 280 units of the Day Surgery General Pack (model FHGE18T) due to sterilization assurance concerns. The company identified that humidity readings in one controlled storage environment fell outside acceptable specifications, making it impossible to confirm that the devices met sterilization requirements.
The affected product lot (2405131) was distributed nationwide to healthcare facilities in Missouri, Minnesota, Massachusetts, Ohio, and Nebraska. These are medical convenience kits used in surgical settings.
No injuries or illnesses have been reported. Healthcare facilities that received affected units should cease using them and contact American Contract Systems or the FDA for return instructions and replacement products.
The recalled product
- Product
- Day Surgery General Pack, FHGE18T; Medical convenience kit
- Manufacturer
- American Contract Systems, Inc.
- Hazard
- contamination-risk
- 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: 00191072210517
- Lot: 2405131
- Exp: 05/13/2025
Distribution
Distributed nationwide across the United States.
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