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U.S. Department of Health and Human Services

Class 2 Device Recall BORN ON ARRIVAL KIT

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 Class 2 Device Recall BORN ON ARRIVAL KITsee related information
Date Initiated by FirmFebruary 06, 2025
Date PostedMarch 14, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1341-2025
Recall Event ID 96343
Product Classification Labor and Delivery Kit - Product Code MLS
ProductBORN ON ARRIVAL KIT , Model No LLBN11B
Code Information UDI-DI 00191072219558 Lots 891241 70-051710 70-052354
Recalling Firm/
Manufacturer		 American Contract Systems Inc
85 Shaffer Park Dr
Tiffin OH 44883-9290
For Additional Information ContactMarlene Jones
419-455-2090
Manufacturer Reason
for Recall		ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
FDA Determined
Cause 2		Process control
ActionThe affected distributor was notified via email on 2/16/25, and an updated letter was provided on 2/18/25. The distributor was instructed to notify their end users. Customers were provided with a list of impacted components which are included in the affected trays. Customers were provided with a labeling template and instructed to add warning labels to affected procedure trays to ensure the affected components are discarded.
Quantity in Commerce54 kits
DistributionUS Nationwide distribution in the state of OH.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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