The Recall Desk
HighFDA (Devices)·Z-2295-2023·Announced 2023-08-09

Medline Procedural Kits Recalled: Ultrasound Gel Sterility Concerns

Medline recalls sterile and non-sterile procedural kits containing ultrasound gel that may not meet sterility specifications. 29,126 units distributed in US and internationally.

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 a Class II FDA recall involving sterile medical procedure kits with potential sterility specification failures in the ultrasound gel component. While no illnesses or injuries have been reported, non-sterile gel in sterile medical procedures creates a significant risk of patient harm through infection.

Plain-English summary

Medline Industries has issued a recall of custom sterile and non-sterile procedural kits containing Turkuaz ultrasound gel due to potential sterility specification failures. A total of 29,126 kits across 14 different model types are affected by this recall.

The issue involves the sterile ultrasound gel component within these kits, which may not meet required sterility specifications. This creates a risk of contamination in sterile medical procedures, including angiography, nerve blocks, and radiology-guided interventions.

The affected kits were distributed worldwide between April 1, 2020 and April 28, 2023, including distribution to the United States, Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, and the United Arab Emirates. Affected models include ANGIOGRAM TRAY, BLOCK TRAY, BMT-NERVE PERIPH PK, CVOR ANGIOGRAPHY PACK, FEMORAL BLOCK TRAY, and multiple nerve block kits.

Healthcare facilities should discontinue use of affected kits and verify they are using products from dates outside the recalled period or from another manufacturer. Healthcare providers should contact Medline Industries for information on how to handle existing inventory.

The recalled product

Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIOGRAM TRAY, Model Number: DYNJ33638J; b. BLOCK TRAY, Model Number: DYNJRA1543; c. BMT- NERVE PERIPH PK, Model Number: DYNJRA1247; d. CVOR ANGIOGRA
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Procedure Kits
Hazard
Affected units
29,126

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: 019348956435. b. Model Number: DYNJRA1543
  • UPC Number: 019348921766. c. Model Number: DYNJRA1247
  • UPC Number: 019348950391. d. Model Number: DYNJ42367B
  • UPC Number: 019348921151. e. Model Number: DYNJRA1739
  • UPC Number: 019348926312. f. Model Number: DYNJ0134147D
  • UPC Number: 088994293734. g. Model Number: DYNJRA1220
  • UPC Number: 088827779503
  • Model Number: DYNJRA1571
  • UPC Number 019348926473. h. Model Number: DYNJRA1109A
  • UPC Number: 019348925132. i. Model Number: DYNJRA0656A
  • UPC Number: 088994222511
  • Model Number: DYNJRA1287A
  • UPC Number: 019348977309
  • Model Number: DYNJRA1604
  • UPC Number 019348929981. j. Model Number: DYNJRA0725
  • UPC Number: 019348926312. k. Model Number: DYNJ51107B
  • UPC Number: 019348981047. l. Model Number: DYNJRA1773
  • UPC Number: 019348986297. m. Model Number: PAIN1622A
  • UPC Number: 019348989169. n. Model Number: DYNJRA1635A
  • UPC Number: 019348936764.

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 →

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