Custom Procedural Kits May Contain Non-Sterile Ultrasound Gel
Medline is recalling sterile and non-sterile procedural kits because the ultrasound gel component may not meet sterility specifications. Approximately 6,939 kits were distributed between April 2020 and 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 is a Class II recall of sterile medical device components where the labeled sterile gel may not meet sterility specifications. Per the rubric, this qualifies as a high-risk product where injury has not yet been reported, warranting a score of 3.
Plain-English summary
Medline Industries, LP is recalling custom sterile and non-sterile procedural kits containing Turkuaz Ultrasound Gel. The recalled products include central catheter insertion trays (Model CVI680C), CVC insertion accessory kits (Model ECVC7880), CVL insertion trays (Model DYNDC1786A), ultrasound-guided PIV insertion kits (Model IVS3635B), and USG PIV insertion kits (Model DYNDV2480A). Approximately 6,939 kits are affected.
The sterile ultrasound gel component within these kits may not meet sterility specifications. The affected kits were distributed between April 1, 2020, and April 28, 2023.
The recalled kits were distributed worldwide to healthcare facilities and distributors in the United States, Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, and the United Arab Emirates.
Healthcare facilities that received these kits should cease use immediately and contact Medline Industries for further instructions regarding the affected lot numbers.
The recalled product
- Product
- Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CENTRAL CATHETER INSERTION TRAY, Model Number: CVI680C; b. CVC INSERTION ACCESSORY KIT, Model Number: ECVC7880; c. CVL INSERTION TRAY, Model Number…
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Procedural Kit
- Hazard
- Affected units
- 6,939
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 (5)
- UPC Number: 065316099294. b. Model Number: ECVC7880
- UPC Number: 019532712961. c. Model Number: DYNDC1786A
- UPC Number: 019348919911. d. Model Number: IVS3635B
- UPC Number: 019348936055. e. Model Number: DYNDV2480A
- UPC Number: 019532732721.
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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