Medline Procedural Kits with Turkuaz Ultrasound Gel May Not Meet Sterility Requirements
Medline is recalling 218,163 sterile procedural kits containing Turkuaz Ultrasound Gel that may not meet sterility specifications. Kits distributed April 2020-April 2023 are used in invasive medical procedures.
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 recall for medical device procedural kits with potential sterility specification failures. No illnesses or injuries are mentioned in the recall announcement. Per the rubric, this represents a risk-of-harm product without reported injury, warranting a score of 3 (High).
Plain-English summary
Medline Industries, LP is recalling 218,163 sterile and non-sterile procedural kits that contain Turkuaz Ultrasound Gel. The affected kits include 43 different model numbers used for medical procedures such as peripheral intravenous catheter insertion, PICC line insertion, arterial line insertion, and midline catheter insertion.
The recall was initiated due to potential sterility specification failures of the ultrasound gel component in these kits. Ultrasound gel that does not meet sterility requirements could pose risks in invasive medical procedures.
The affected 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. All lot numbers of the affected model numbers distributed between April 1, 2020, and April 28, 2023, are included in this recall.
Healthcare facilities and distributors should immediately stop using affected kits and verify their inventory using the provided model numbers and UPC codes. Contact Medline Industries or the FDA for proper handling and disposition of recalled products.
The recalled product
- Product
- Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ADULT EPIV INSERTION TRAY, Model Number: DYNDA2482; b. ARTERIAL LINE START KIT, Model Number: ART920; c. CENTRAL LINE INSERTION TRAY, Model Number…
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 218,163
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: 10193489198188. b. Model Number: ART920
- UPC Number: 10653160327899. c. Model Number: DT19810
- UPC Number: 10653160285656. d. Model Number: CVI4915
- UPC Number: 10653160355489. e. Model Number: IVS3770
- UPC Number: 10653160328230. f. Model Number: DYNDV2407A
- UPC Number: 019348981701. g. Model Number: MID0005
- UPC Number: 10653160349181. h. Model Number: CVI4340
- UPC Number: 10653160309475. i. Model Number: MIDST04011
- UPC Number: 10653160350699. j. Model Number: MID0001
- UPC Number: 10193489381627. k. Model Number: DYNJ80141MB
- UPC Number: 10889942733415
- Model Number: MID0003
- UPC Number: 10653160349334. l. Model Number: PICC0009A
- UPC Number: 10193489760231. m. Model Number: DYNJ80152MB
- UPC Number: 10889942733422. n. Model Number: DYNDA2509A
- UPC Number: 10193489196986
- Model Number: MNS8765
- UPC Number: 10653160270515. o. Model Number: DYNDC2120B
- UPC Number: 10193489198270. p. Model Number: CVI3740A
- UPC Number: 10653160324416. q. Model Number: IVS3990
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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