The Recall Desk
HighFDA (Devices)·Z-2296-2023·Announced 2023-08-09

Medline Procedural Kits Recalled for Potential Sterility Specification Failure

Medline has recalled 63,823 custom procedural kits due to potential sterility specification failure of the ultrasound gel component. The affected kits were distributed worldwide from April 2020 through April 2023.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall of medical devices with potential sterility failure. No illnesses or injuries are reported. This qualifies as a risk-of-harm product where injury has not yet been reported, per FDA severity criteria.

Plain-English summary

Medline Industries, LP has recalled 63,823 custom sterile and non-sterile procedural kits containing Turkuaz Ultrasound Gel. These kits are used in angiography and other interventional cardiovascular procedures. The recall was initiated because the sterile ultrasound gel component within the kits has the potential to not meet sterility specifications.

The affected products include multiple kit models and variants used for various angiography and cardiovascular procedures. These include ANGIO kits, ANGIO BASIN SET, ANGIO CATH COMBINED PACK, ANGIO DRAPE PACK, ANGIOGRAPHY DRAPE PACK, ANGIOGRAPHY PACK, CATH LAB PACK, and many additional variants. All lot numbers of the specified models distributed from Medline between April 1, 2020, and April 28, 2023, are included in this recall.

The recalled kits were distributed worldwide, including throughout the United States, and in Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, and the United Arab Emirates. This is an FDA Class II recall with recall number Z-2296-2023.

The recalled product

Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIO, Model Number: DYNJ902507B; b. ANGIO BASIN SET, Model Numbers: DYNJ46043D, DYNJ46043F; c. ANGIO CATH COMBINED PACK, Model Numbers: DYNJ43609K, DYNJ43
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Angiography Kits
Hazard
Affected units
63,823

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • UPC Number: 088994278118. b. Model Number: DYNJ46043D
  • UPC Number: 019348935036
  • Model Number: DYNJ46043F
  • UPC Number: 019348985672. c. Model Number: DYNJ43609K
  • UPC Number: 019348950140
  • Model Number: DYNJ43609L
  • UPC Number 019348960178
  • Model Number: DYNJ43609M
  • UPC Number 019348962744
  • Model Number: DYNJ43609N
  • UPC Number 019348928212. d. Model Number: DYNJ17624B
  • UPC Number: 019348986729
  • Model Number: DYNJ44320F
  • UPC Number 019348943551. e. Model Number: DYNJ47951A
  • UPC Number: 019348960984. f. Model Number: DYNJ40632C
  • UPC Number: 019348946117. g. Model Number: DYNJ30141
  • UPC Number: 019348956435
  • Model Number: DYNJ34361
  • UPC Number 088438934847
  • Model Number: DYNJ42903B

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 50 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 50 products in this recall →

Related recalls

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

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Same hazard · sterility failure

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