Birth Delivery Kit Recalled Due to Unconfirmed Sterilization Assurance
American Contract Systems Inc recalls the Born on Arrival Kit due to inability to confirm sterilization assurance. Unsterilized equipment could delay or prolong newborn treatment.
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 is an FDA Class II medical device for newborn care where sterilization assurance cannot be confirmed, meeting the rubric criterion for Score 3: 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
American Contract Systems Inc is recalling the Born on Arrival Kit, Model No LLBN11B. The recall affects 54 kits distributed nationwide in Ohio.
The company is unable to confirm that product sterilization assurance requirements were met. This means the medical equipment may not be properly sterilized.
Unsterilized equipment could result in loss or lack of functionality, potentially delaying or prolonging treatment for newborns.
The recalled product
- Product
- BORN ON ARRIVAL KIT , Model No LLBN11B
- Manufacturer
- American Contract Systems Inc
- Hazard
- sterilization-failure
- loss-of-functionality
- treatment-delay
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 (1)
- UDI-DI 00191072219558 Lots 891241 70-051710 70-052354
Distribution
Distributed nationwide across the United States.
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