🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: December 23, 2022 Quest Medical Infusion Pumps Nationwide

What Should You Do?

  1. Check if you have this product:
    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)
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Quest Medical, Inc.
Reason for Recall:
Delivery Sets may have tubing that could become detached that could result in patient infection.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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

Product Codes/Lot Numbers:

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)

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1100-2023

Related Recalls

Q2 Multiport Extension set, REF: 9520, Rx Only Sterile, single use non-pyrogenic intravenous fluid administration sets with a multiport IV manifold and integrated back-check valves, pre-attached needleless injection sites, drip chamber and roller clamps.

Quest Medical

Class I - Dangerous

For administration of intravenous fluids to a patient s vascular system utilizing needle-free components and I.V. manifold for multiple simultaneous intravenous therapy via gravity, syringe, or infusion pump. Use of a needle-free system may aid in the prevention of needle-stick injuries.

Jul 14, 2023 Surgical Instruments View Details →

Ref 801168, MPS Top Cover Replacement Kit, 1 UNITS, UDI: (01)2 0634624 81168 7 (11)190916 (17)290913 (10)059135 (The device is a component of the MPS Console used as replacements for worn or damaged MPS Console top covers)

Quest Medical

Class I - Dangerous

Additive and Arrest Agent Labels on the MPS Top Cover Replacement Kit, a replacement for worn or damaged MPS Console Top Covers for cardiopulmonary bypass heat exchanger, used to deliver whole blood to the heart during open heart surgery, were swapped and incorrectly placed. This could lead to over delivery of potassium by the user requiring medical intervention.

Dec 17, 2019 Other Medical Devices Nationwide View Details →