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.
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 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
- Affected units
- 54
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
Part of a larger recall action
This product is one of 32 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.
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