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U.S. Department of Health and Human Services

Class 2 Device Recall Quest Precision Delivery Sets

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  Class 2 Device Recall Quest Precision Delivery Sets see related information
Date Initiated by Firm December 23, 2022
Date Posted February 07, 2023
Recall Status1 Open3, Classified
Recall Number Z-1100-2023
Recall Event ID 91409
510(K)Number K202672  
Product Classification Set, administration, intravascular - Product Code FPA
Product Precision Delivery Set with Filter, REF: PD06F; and Precision Delivery Set with Trifurcated Luer, REF: PDT05CV2
Code Information 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)
Recalling Firm/
Manufacturer		 Quest Medical, Inc.
1 Allentown Pkwy
Allen TX 75002-4206
For Additional Information Contact
972-390-9800
Manufacturer Reason
for Recall		 Delivery Sets may have tubing that could become detached that could result in patient infection.
FDA Determined
Cause 2		 Process control
Action 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.
Quantity in Commerce 13,900
Distribution US Nationwide distribution in the state of MA.
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.
510(K) Database 510(K)s with Product Code = FPA and Original Applicant = Quest Medical, Inc.
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