FDA Recalls Medline Procedural Kits Due to Potential Sterility Failure
Medline Industries is recalling 22 procedural kits because the included ultrasound gel may not be sterile as labeled. The kits were distributed worldwide.
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 recall involving a medical device with potential sterility failure. No illnesses or injuries have been reported, and the hazard is theoretical rather than confirmed. The risk is limited to potential infection if non-sterile gel is used in medical procedures.
Plain-English summary
Medline Industries, LP is recalling Custom Sterile and Non-Sterile Procedural Kits that contain Turkuaz Ultrasound Gel. The specific recalled product is labeled as PREMIUM CLOSUREPLUS PACK, Model Number DYNJ54326A (UPC 019532732764). A total of 22 kits are affected, with all lot numbers distributed from April 1, 2020 through April 28, 2023.
The sterile ultrasound gel component included in these kits may not meet sterility specifications. If sterile medical products fail to maintain proper sterility, they can potentially introduce infection when used in clinical procedures.
The affected kits have been distributed worldwide, including throughout the United States and to Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, and the United Arab Emirates. Healthcare facilities and consumers with these kits should discontinue use and contact Medline Industries for further instructions.
The recalled product
- Product
- Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PREMIUM CLOSUREPLUS PACK, Model Number: DYNJ54326A.
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Procedural Kits
- Hazard
- sterility-failure
- infection-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: 019532732764.
Distribution
Distributed nationwide across the United States.
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