Agency classClass IIOur severity:High FDA (Devices)·Z-2314-2023·Announced 2023-08-09

Medline procedural kits with potentially non-sterile ultrasound gel recalled

Medline Industries is recalling 80 custom procedural kits containing ultrasound gel that may not meet sterility specifications. Kits were distributed worldwide from April 2020 to April 2023.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 a risk-of-harm medical device with potential for patient contamination from non-sterile components. No illnesses or injuries are reported in the source material.

Plain-English summary

Medline Industries, LP has issued a Class II recall of custom sterile and non-sterile procedural kits (Model DYNJ60126B, UPC 019532711883) containing Turkuaz ultrasound gel. Approximately 80 kits were distributed worldwide between April 1, 2020 and April 28, 2023, including to the United States, Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, and the United Arab Emirates.

The recall was issued due to the potential for the sterile ultrasound gel component to not meet sterility specifications. Gel labeled as sterile may not actually be sterile, creating a risk of contamination or infection during medical procedures where these kits are used.

All lot numbers of the affected model (DYNJ60126B) that were distributed during the specified timeframe are included in this recall. Facilities or providers that may have received these kits should verify whether they possess any affected products and contact Medline Industries for further guidance on product replacement or return.

The recalled product

Product: Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PACK ENDO AAA HYBRID CHRG, Model Number: DYNJ60126B;
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Category: Medical Device — Procedural / Surgical Kits
Hazard: sterility-failure
contamination-risk
Affected units: 80

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 (1)

UPC Number: 019532711883.

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 →

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

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