Quest Medical, Inc. Recall 91409
Description: Precision Delivery Set with Filter, REF: PD06F; and Precision Delivery Set with Trifurcated Luer, REF: PDT05CV2
Quest Medical, Inc. Recall 91409 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-1100-2023 |
Event ID | 91409 |
Event Description | Precision Delivery Set with Filter, REF: PD06F; and Precision Delivery Set with Trifurcated Luer, REF: PDT05CV2 |
Product Type | Devices |
Distribution | US Nationwide distribution in the state of MA. |
Quantity | 13,900 |
Recall Reason | Delivery Sets may have tubing that could become detached that could result in patient infection. |
Device Classification | 20230215 |
Device Code Info | REF/UDI-DI/Lots (Expiration Dates): PD06F/00634624911062/65824 (4/18/2025), 65826 (4/18/2025), 66069 (5/16/2025); PDT05CV2/00634624921412/66645 (7/11/2025) |
Center Classification Date | 20230207 |
Recall Initiation Date | 20221223 |
Recalling Firm | Quest Medical, Inc. |
Initial Notification | Letter |
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