Agency classClass IIOur severity:High FDA (Devices)·Z-2337-2023·Announced 2023-08-09

Medline Procedural Kits Recalled Due to Potential Sterility Specification Failures

Medline Industries is recalling sterile procedural kits containing ultrasound gel that may not meet sterility specifications. The kits were distributed worldwide between April 2020 and 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: This is a Class II medical device recall with no reported illnesses or injuries. The recall addresses potential failure to meet sterility specifications on a component used in invasive procedures, constituting a risk-of-harm product where injury has not yet been reported, consistent with High severity criteria.

Plain-English summary

Medline Industries, LP is recalling sterile and non-sterile procedural kits that contain Turkuaz Ultrasound Gel. The affected kits are the CATH LAB PACK (Model DYNJ58351A) and PV CAROTID PACK (Model DYNJ63341B).

The recall was issued because the sterile ultrasound gel component within the kits may not meet sterility specifications. A product labeled and intended to be sterile that fails to meet sterility standards poses a potential health risk when used in invasive medical procedures.

The kits were distributed worldwide from April 1, 2020 through April 28, 2023. Distribution included the United States, Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, and the United Arab Emirates. A total of 624 kits were affected.

Healthcare facilities and users who have received these kits should immediately stop using them and contact Medline Industries for replacement or disposal instructions.

The recalled product

Product: Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CATH LAB PACK, Model Number: DYNJ58351A; b. PV CAROTID PACK, Model Number: DYNJ63341B;
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Category: Medical Device — Procedural Kit
Hazard: sterility-failure
contamination-risk
Affected units: 624

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 (2)

UPC Number: 088827773939. b. Model Number: DYNJ63341B
UPC Number: 019348995809.

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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