Surgical Procedural Kits Recalled for Potential Sterility Specification Failures
Medline Industries is recalling 16,143 custom surgical procedural kits because the sterile ultrasound gel component may not meet sterility specifications. The kits were distributed worldwide from April 2020 to April 2023.
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: FDA Class II recall with no reported illnesses or injuries. However, the hazard involves potentially non-sterile components in surgical kits where sterility is critical, creating a risk-of-harm scenario that justifies a High rating per the rubric criterion for products presenting a risk of harm where injury has not yet been reported.
Plain-English summary
Medline Industries is recalling custom sterile and non-sterile procedural kits containing Turkuaz ultrasound gel. The recall involves 16,143 kits with multiple model numbers, including Ablation Pack, AV Fistula Pack, Bariatric Kit, and numerous other specialized surgical and procedural packs. All lot numbers of the affected models were distributed from April 1, 2020 through April 28, 2023.
The sterile ultrasound gel component within these kits has the potential to not meet sterility specifications. In surgical and medical procedures where sterility is essential, non-sterile gel could pose a risk of infection or other patient harm.
The recalled kits were distributed worldwide, including throughout 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. ABLATION PACK, Model Number: DYNJ40629B; b. AV FISTULA PACK, Model Number: DYNJ81410B; c. BARIATRIC KIT, Model Number: DYNJ901145G; d. BARIATRIC LAP
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Kits
- Hazard
- sterility-non-compliance
- infection-risk
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: 088827777869. b. Model Number: DYNJ81410B
- UPC Number: 019532732082. c. Model Number: DYNJ901145G
- UPC Number: 019348985021. d. Model Number: DYNJC9299M
- UPC Number: 019348926312
- Model Number: DYNJC9299O
- UPC Number: 019532718840. e. Model Number: DYNJ24459P
- UPC Number: 019348935534. f. Model Number: DYNJ36242
- UPC Number: 088438951744. g. Model Number: DYNJ60667C
- UPC Number: 019348940759
- Model Number: DYNJ60667D
- UPC Number: 019348986151
- Model Number: DYNJ60667F
- UPC Number: 019532702361
- Model Number: DYNJ83942
- UPC Number: 019532731798. h. Model Number: DYNJ905761A
- UPC Number: 019348946321. i. Model Number: DYNJ68447B
- UPC Number: 019532703416. j. Model Number: DYNJ69204A
- UPC Number: 019532711427. k. Model Number: DYNJ901296B
- UPC Number: 019348992335. l. Model Number: DYNJ66867A
- UPC Number: 019348998623. m. Model Number: DYNJ0426069N
Distribution
Distributed nationwide across the United States.
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