| | Class 1 Device Recall Mallinckrodt |  |
| Date Initiated by Firm | August 08, 2023 |
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| Date Posted | September 09, 2023 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2450-2023 |
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| 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. |
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| 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
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| For Additional Information Contact | Milicent Brooks
908-238-6600 |
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Manufacturer Reason
for Recall | The One-Way Valve, 22F x 22M may stick and prevent or reduce the flow of ventilated air or oxygen. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| 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. |
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| Quantity in Commerce | 13,602 units |
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| Distribution | Worldwide Distribution |
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| Total Product Life Cycle | TPLC Device Report |
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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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