Medline procedural kits with ultrasound gel may not meet sterility specifications
Medline Industries recalls 146,157 custom procedural kits distributed April 2020 to April 2023 because the sterile ultrasound gel component may not meet 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 an FDA Class II medical device recall involving potential sterility specification failure. Although no illnesses or injuries have been reported, the hazard represents a risk-of-harm product—non-sterile ultrasound gel labeled as sterile could introduce infection if used in surgical procedures requiring sterility.
Plain-English summary
Medline Industries, LP has recalled 146,157 custom sterile and non-sterile procedural kits containing Turkuaz ultrasound gel. The affected kits were distributed between April 1, 2020 and April 28, 2023 and include numerous models used for vascular access procedures, such as AV fistula packs, central line insertion kits, PICC line packs, and arterial line kits.
The recall was initiated because the sterile ultrasound gel component within these kits has the potential to not meet sterility specifications. If kits labeled as sterile do not actually meet sterility standards, they could pose a risk of infection if used in medical procedures that require sterile products.
The recalled kits were 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 that received these kits should identify affected units by model number and UPC, discontinue use of the affected lots, and contact Medline Industries for return or replacement instructions.
The recalled product
- Product
- Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. A V FISTULA, Model Number: DYNJ65711; b. ACCESS CATHETER, Model Number: DYNJ64141A; c. ACCESS PICC PACK, Model Number: DYNJ40682B; d. ADULT EPIV INSERTION…
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Procedural Kits
- Hazard
- Affected units
- 146,157
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: 019348928509. b. Model Number: DYNJ64141A
- UPC Number: 019532727957. c. Model Number: DYNJ40682B
- UPC Number: 088994226721. d. Model Number: DYNDA2482
- UPC Number: 019348935160. e. Model Number: DYNJ67534
- UPC Number: 019348940932. f. Model Number: DYNJ81725
- UPC Number: 019532713675. g. Model Number: ART900
- UPC Number: 065316034254. h. Model Number: DYNJ49235D
- UPC Number: 019348989433. i. Model Number: DYNJ53095A
- UPC Number: 019532714872
- Model Number: DYNJ55169G
- UPC Number: 019348996756. j. Model Number: DYNJ64143A
- UPC Number: 019348928481
- Model Number: DYNJ905219A
- UPC Number: 019348928721
- Model Number: DYNJ906341C
- UPC Number: 019348981630
- Model Number: DYNJ906945
- UPC Number: 019348929927. k. Model Number: DYNJ52093I
- UPC Number: 019348933747
- Model Number: DYNJ62733
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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