The Recall Desk
HighFDA (Devices)·Z-2293-2023·Announced 2023-08-09

Medline Procedural Kits Recalled Due to Potential Sterility Failure

Medline has recalled approximately 29,277 procedural kits containing ultrasound gel because the gel component may not meet sterility specifications. The recall covers kits distributed worldwide from April 2020 to 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: This is an FDA Class II recall for potential sterility failure in medical device gel used in invasive procedures. The hazard is theoretical with no reported illnesses or injuries, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Medline Industries has recalled approximately 29,277 custom procedural kits containing Turkuaz Ultrasound Gel used for medical procedures such as nerve blocks and ultrasound-guided interventions. The kits involve 26 different model numbers manufactured by Medline.

The sterile gel component may not meet FDA sterility specifications. This potential deficiency could compromise patient safety in procedures utilizing these kits.

The affected kits were distributed worldwide between April 1, 2020, and April 28, 2023, including the United States, Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, and the United Arab Emirates.

Healthcare facilities in possession of these kits should contact Medline Industries for recall instructions and proper disposition of the affected products.

The recalled product

Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a.18G CPNB 20G STYLETED CATHETER, Model Number: DYNJRA1869; b. ACUTE PAIN BLOCK TRAY, Model Number: DYNJRA0949C; c. ANESTHESIA BLOCK KIT, Model Number: DYNJRA
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Procedural Kits / Ultrasound Gel
Hazard
Affected units
29,277

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: 019532701881. b. Model Number: DYNJRA0949C
  • UPC Number: 019348966504. c. Model Number: DYNJRA1864
  • UPC Number: 019348926312. d. Model Number: DYNJRA1893
  • UPC Number: 019532706282. e. Model Number: DYNJRA1998
  • UPC Number: 019532719429. f. Model Number: DYNJRA1978
  • UPC Number: 019348926312
  • Model Number: DYNJRA1978A
  • UPC Number: 019532732040
  • Model Number: SAMPA0109
  • UPC Number: 019532709698. g. Model Number: DYNJRA1739A
  • UPC Number: 019348992495. h. Model Number: DYNJRA2027
  • UPC Number: 019532704037
  • Model Number: DYNJRA1900
  • UPC Number: 019532708225. k. Model Number: DYNJRA2055
  • UPC Number: 019532725516. l. Model Number: DYNJRA0827A
  • UPC Number: 019348921446. m. Model Number: DYNJRA0881
  • Model Number: DYNJRA1847
  • UPC Number: 019348999366
  • Model Number: DYNJRA1975
  • UPC Number: 019532716324. n. Model Number: DYNJRA2028

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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