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Open, Classified

Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used with ventilators.

FDA Recall Z-2450-2023 · Posted 2023-09-09

Recalling FirmMallinckrodt Manufacturing LLC
Recall StatusOpen, Classified
Product CodeBZO
Date Initiated2023-08-08
Product Quantity13,602 units

Reason for Recall

The One-Way Valve, 22F x 22M may stick and prevent or reduce the flow of ventilated air or oxygen.

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.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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