Medline Procedural Kit Ultrasound Gel Sterility Specification Failure
Medline Industries is recalling procedural kits containing ultrasound gel that may not meet sterility specifications. The affected kits were distributed to healthcare facilities worldwide from 2020 to 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 medical device recall for a product labeled as sterile. The potential failure of the ultrasound gel to meet sterility specifications presents a risk of infection or contamination during medical procedures. No illnesses or injuries are reported.
Plain-English summary
Medline Industries, LP is recalling Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel (DR MOTT DRAPE PACK, Model DYNJ42065B, UPC 088827789355). A total of 36 kits are affected by this recall.
The ultrasound gel component within these kits may not meet sterility specifications. Non-sterile materials in products intended to be sterile can pose a risk of infection or contamination during medical procedures.
The affected kits were distributed worldwide from April 1, 2020 through April 28, 2023. Distribution included the United States and Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, and the United Arab Emirates.
Customers in possession of these kits should discontinue use. Healthcare facilities should identify affected inventory by lot number and model number, quarantine the kits, and follow appropriate disposal procedures.
The recalled product
- Product
- Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DR MOTT DRAPE PACK, Model Number: DYNJ42065B
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Procedural Kits
- Hazard
- sterility-failure
- contamination-risk
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: 088827789355.
Distribution
Distributed nationwide across the United States.
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