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U.S. Department of Health and Human Services

Class 1 Device Recall Mallinckrodt

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  Class 1 Device Recall Mallinckrodt see related information
Date Initiated by Firm August 08, 2023
Date Posted September 09, 2023
Recall Status1 Open3, Classified
Recall Number Z-2450-2023
Recall Event ID 92799
Product Classification Set, tubing and support, ventilator (w harness) - Product Code BZO
Product Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used with ventilators.
Code Information a) UDI/DI 10810055283460, Lot Codes: 74L2001714, 74L2001715, 74L2001716, 74M2001125, 74B2100237; b) UDI/DI 10810055283467, Lot Codes: 74L2001714, 74L2001715, 74L2001716, 74M2001125, 74B2100237
Recalling Firm/
Manufacturer
Mallinckrodt Manufacturing LLC
6603 Femrite Dr
Madison WI 53718-6801
For Additional Information Contact Milicent Brooks
908-238-6600
Manufacturer Reason
for Recall
The One-Way Valve, 22F x 22M may stick and prevent or reduce the flow of ventilated air or oxygen.
FDA Determined
Cause 2
Under Investigation by firm
Action Mallinckrodt Pharmaceuticals issued an URGENT: MEDICAL DEVICE RECALL NOTICE to its consignees on 08/08/2023 via FedEx. the notice explained the issue, risks associated with the failure, and requested the return of the device.
Quantity in Commerce 13,602 units
Distribution Worldwide Distribution
Total Product Life Cycle TPLC 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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