Procedural Kits with Ultrasound Gel May Not Meet Sterility Specifications
Medline Industries is recalling 144 custom procedural kits containing Turkuaz Ultrasound Gel because the sterile gel component may not meet required sterility specifications.
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 risk-of-harm medical device where sterile procedural components may not meet sterility specifications. No illnesses or injuries have been reported. As a Class II recall without reported hospitalizations and with a theoretical rather than confirmed hazard, a score of 3 applies.
Plain-English summary
Medline Industries, LP is recalling Custom Sterile and Non-Sterile Procedural Kits (model DBD-FLAP HARVEST PACK, model number DYNJ58575C) containing Turkuaz Ultrasound Gel. The affected kits were distributed worldwide between April 1, 2020 and April 28, 2023.
The ultrasound gel component labeled as sterile may not meet required sterility specifications. This defect could result in non-sterile material being used during sterile procedures, creating a potential risk of contamination.
The recall affects all lot numbers of model DYNJ58575C (UPC 019532714414) distributed during the specified timeframe. Products were distributed in the United States, Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, and the United Arab Emirates.
Healthcare facilities that have received these kits should immediately discontinue use and contact Medline Industries for instructions regarding replacement or return of the recalled products.
The recalled product
- Product
- Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DBD-FLAP HARVEST PACK, Model Number: DYNJ58575C
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 144
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: 019532714414.
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.
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