Procedural Kits with Ultrasound Gel May Not Meet Sterility Standards
Medline is recalling 1,130 custom sterile procedural kits because the ultrasound gel component may not meet sterility specifications. The 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: This recall involves a potential sterility specification failure on a medical device component used in clinical procedures, representing a risk of harm through possible contamination. The source does not report any illnesses or injuries, making this a theoretical hazard situation that warrants a score of 3 per the rubric.
Plain-English summary
Medline Industries is recalling 1,130 custom sterile and non-sterile procedural kits labeled as STERILE SET FOR IMPLANT-LF (Model OST011F) that contain Turkuaz ultrasound gel.
The ultrasound gel component within these kits may not meet sterility specifications. Because these sterile procedural kits are used in medical implant procedures, failure to meet sterility standards could result in contamination.
These kits were distributed worldwide, including throughout the United States, Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, and the United Arab Emirates. All lot numbers of Model OST011F with UPC 019532709134 distributed between April 1, 2020, and April 28, 2023, are affected.
Consumers and healthcare providers who have these kits should discontinue use and contact Medline Industries or their supplier for instructions on return or replacement. No illnesses or injuries have been reported to date.
The recalled product
- Product
- Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as STERILE SET FOR IMPLANT-LF, Model Number: OST011F.
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Procedural Kits
- Hazard
- Affected units
- 1,130
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: 019532709134
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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