RecallDepth

Precision Delivery Set with Filter, REF: PD06F; and Precision Delivery Set with Trifurcated Luer, REF: PDT05CV2

Company
Quest Medical, Inc.
Recall Initiated
December 23, 2022
Posted
February 7, 2023
Recall Number
Z-1100-2023
Quantity
13,900
Firm Location
Allen, TX

Reason for Recall

Delivery Sets may have tubing that could become detached that could result in patient infection.

Distribution

US Nationwide distribution in the state of MA.

Lot / 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)

Root Cause

Process control

Action Taken

On 12/23/22, the recall notice was distributed. The customer was asked to return affected devices and to call 1-800-627-0226, extension 311, if they had any questions.

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