Medline Procedural Kits Recalled for Ultrasound Gel Sterility Defect
Medline Industries recalls 104,755 procedural kits due to potential sterility defect in ultrasound gel component. No illnesses or injuries have been reported.
What this means for you
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: Classified as FDA Class II with a potential sterility defect in medical device components. No illnesses or injuries are reported in the source material. Per rubric: when the source explicitly states no illnesses/injuries and the hazard is theoretical, the maximum score is 3 (High).
Plain-English summary
Medline Industries, LP is recalling custom sterile and non-sterile procedural kits containing Turkuaz Ultrasound Gel. The recalled kits include multiple model numbers spanning CVC bundles, catheter insertion bundles, angiography packs, and other surgical procedure packs, totaling 104,755 units affected.
The labeled sterile ultrasound gel component within these kits has a potential to not meet sterility specifications. This non-compliance with sterility standards represents a potential risk in clinical procedures where the kits are used.
The affected kits were distributed worldwide from April 1, 2020 through April 28, 2023 to the United States and to Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, and the United Arab Emirates. Healthcare facilities and medical professionals using these kits should verify that their supplies are not on the recalled lot list by checking the provided model numbers and UPC codes. If recalled kits are identified, they should be removed from service and the manufacturer contacted for replacement or guidance.
The recalled product
- Product
- Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. MULTI-LUMEN CVC BUNDLE KIT, Model Number: ECVC475; b. MULTI-LUMEN CVC INSERTION BUNDLE, Model Number: ECVC3900; c. MULTIMED 16G 1L 20CM CVC STOCK+BUNDLE US, Mode
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- Affected units
- 104,755
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: 10653160333081. b. Model Number: ECVC3900
- UPC Number: 10653160334828. c. Model Number: STCVC20US
- UPC Number: 10653160339076. d. Model Number: STCVC21US
- UPC Number: 10653160339045. e. Model Number: ECVC6585A
- UPC Number: 10653160338826. f. Model Number: ECVC7235A
- UPC Number: 10653160354550. g. Model Number: STCVC03US
- UPC Number: 10653160339212. h. Model Number: ECVC6655A
- UPC Number:10653160339267. i. Model Number: ECVC7935
- UPC Number: 10653160353669. j. Model Number: STCVC04US
- UPC Number: 10653160339199. k. Model Number: ECVC7670
- UPC Number:10653160348054. l. Model Number: ECVC7090
- UPC Number: 10653160339243. m. Model Number: ECVC6930
- UPC Number:10653160339250. n. Model Number: STCVC13US
- UPC Number: 10653160339137. o. Model Number: DYNJ47646D
- UPC Number: 019348995047
- Model Number: DYNJ47646F
- UPC Number: 019532715551
- Model Number: DYNJ47646G
- UPC Number: 019532717502
- Model Number: DYNJ47646I
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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