FDA Medical Device Recalls (openFDA)
Quest Medical, Inc.: Precision Delivery Set with Filter, REF: PD06F; and Precision Delivery Set with Trifurcated Luer, REF: PDT05CV2
- Recall number
- Z-1100-2023
- Recalling firm
- Quest Medical, Inc.
- Product
- Precision Delivery Set with Filter, REF: PD06F; and Precision Delivery Set with Trifurcated Luer, REF: PDT05CV2
- Status
- Open, Classified
- Initiated
- 2022-12-23
- Posted
- 2023-02-07
- Terminated
- not on file
- Reason
- Delivery Sets may have tubing that could become detached that could result in patient infection.
- Root cause
- 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
- 13,900
- Distribution
- US Nationwide distribution in the state of MA.
- Lot, serial or model codes
- 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)
- 510(k) numbers
- ["K202672"]
- PMA numbers
- not on file
- Product code
- FPA
- Firm FEI
- 3001665800
- Firm city
- Allen
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28