Medline Procedural Kits Recalled for Potential Sterility Failure in Ultrasound Gel
Medline is recalling 6,733 custom procedural kits due to potential sterility failure in the Turkuaz ultrasound gel component. The gel 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 FDA Class II recall involves potential sterility failure in a medical device component (ultrasound gel) used in procedural kits. Although no illnesses or injuries have been reported, non-sterile gel in medical procedures poses a direct risk of infection, meeting the criteria for a high-severity rating as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Medline Industries is recalling 6,733 custom sterile and non-sterile procedural kits containing Turkuaz ultrasound gel. The affected products include four models: CVC Pack (DYNJ46967F), Endovenous Ablation Pack (DYNJ64059), Endovenous Core Pack (DYNJ62557), and TVS4000 Endovenous Pack (TVS4000K).
The sterile ultrasound gel component within these kits may not meet sterility specifications. All lot numbers of these models distributed between April 1, 2020 and April 28, 2023 are affected, identified by UPC codes 019348957604, 019348978270, 019348966915, and 081698202386.
The 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 may have received these affected products.
Healthcare facilities in possession of the affected models and lot numbers should immediately cease using these kits. Contact Medline Industries to report possession and arrange for replacement or return of the affected products.
The recalled product
- Product
- Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CVC PACK, Model Number: DYNJ46967F; b. ENDOVENOUS ABLATION PACK, Model Number: DYNJ64059; c. ENDOVENOUS CORE PACK: DYNJ62557; d. TVS4000 ENDOVENOUS…
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Procedural Kits
- Affected units
- 6,733
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 (4)
- UPC Number: 019348957604. b. Model Number: DYNJ64059
- UPC Number: 019348978270. c. Model Number: DYNJ62557
- UPC Number: 019348966915. d. Model Number: TVS4000K
- UPC Number: 081698202386.
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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