Medline sterile procedural kits recalled for potentially non-sterile gel
Medline is recalling 83,541 procedural kits because the included ultrasound gel component 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 is a Class II risk-of-harm medical device recall where the labeled sterile component may not meet sterility specifications. No illnesses or injuries have been reported, consistent with Score 3 per the rubric.
Plain-English summary
Medline Industries is recalling 83,541 sterile and non-sterile procedural kits that contain Turkuaz Ultrasound Gel. The recalled products include custom procedural kits with various model numbers, including 7F 20CM Triple Lumen CVC Bundle, A V Graft, AAA packs, ablation packs, and many other surgical and interventional kits.
The ultrasound gel component labeled as sterile within these kits may not meet required sterility specifications. All lot numbers for the affected models distributed by Medline between April 1, 2020 and April 28, 2023 are included in this recall.
The affected kits were distributed worldwide to the United States and internationally to Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, and the United Arab Emirates.
The recalled product
- Product
- Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. 7F, 20CM TRIPLE LUMEN CVC BUNDLE, Model Number: ECVC4740; b. A V GRAFT, Model Number: DYNJ36212C; c. AAA, Model Number: DYNJ905651, DYNJ905651A, DYNJ905651B…
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 83,541
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 (20)
- UPC Number: 10653160335214. b. Model Number: DYNJ36212C
- UPC Number: 088994288566. c. Model Number: DYNJ905651
- UPC Number: 088827778831
- Model Number: DYNJ905651A
- UPC Number: 019348968651
- Model Number: DYNJ905651B
- UPC Number: 019348992506. d. Model Number: DYNJ44918C
- UPC Number: 019348976679. e. Model Number: DYNJ44847G
- UPC Number: 019348962983. f. Model Number: DYNJ62540
- UPC Number: 019348966647
- Model Number: DYNJ64068
- UPC Number: 019348978313. g. Model Number: DYNJ53658A
- UPC Number: 088994268440. h. Model Number: DYNDH1159A
- UPC Number: 088994288165. i. Model Number: DYNJ69017
- UPC Number: 019348987815. j. Model Number: DYNJ901348D
- UPC Number: 019348959468. k. Model Number: DYNJV0275F
- UPC Number: 019348926312. l. Model Number: DYNJ38714B
- UPC Number: 088994260193. m. Model Number: DYNJ63576
- UPC Number: 019348976954
- Model Number: DYNJ63576A
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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