Medline surgical procedure kits recalled for potential sterility defect
Medline Industries is recalling 43,149 custom sterile and non-sterile procedural kits because the included Turkuaz ultrasound gel may not meet sterility specifications. The kits were distributed worldwide from April 2020 to April 2023.
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 of surgical procedure kits with a potential sterility defect. No illnesses or injuries have been reported. Per the severity rubric, the combination of an FDA Class II classification and the absence of documented harm results in a High score, as the risk-of-harm exists but injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling 43,149 custom sterile and non-sterile procedural kits. The recalled kits, distributed from April 1, 2020 through April 28, 2023, contain Turkuaz ultrasound gel and are used in various surgical procedures including open-heart surgery, vascular procedures, and other interventional operations.
The FDA has determined that the labeled sterile ultrasound gel component within these kits has the potential to not meet sterility specifications. This is a Class II recall issued by the Food and Drug Administration.
The affected kits were distributed worldwide, including throughout the United States and to the following countries: Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, and the United Arab Emirates. Multiple model numbers and corresponding UPC codes are included in this recall.
Customers who received these kits should stop using them and contact Medline Industries for further instructions regarding return or replacement. Consult the FDA recall notice (Z-2302-2023) for the complete list of affected model numbers and lot information.
The recalled product
- Product
- Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. OPEN HEART CDS-LF, Model Number: CDS840451L; b. OPEN HEART LINE SET UP, Model Number: DYNJ908179, DYNJ908179A; c. OPEN HEART PACK, Model Number: DYNJ43741B…
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 43,149
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: 019532715163. b. Model Number: DYNJ908179
- UPC Number: 019348999908
- Model Number: DYNJ908179A
- UPC Number: 019532722257. c. Model Number: DYNJ43741B
- UPC Number: 088994282107
- Model Number: DYNJ66216
- UPC Number: 019348932622
- Model Number: DYNJ66216A
- UPC Number: 019348991365
- Model Number: DYNJ66216B
- UPC Number: 019532703430
- Model Number: DYNJ66216C
- UPC Number: 019532734492. d. Model Number: DYNJ53984G
- UPC Number: 019532728288. e. Model Number: DYNJ0283397T
- UPC Number: 019348956435
- Model Number: DYNJ0283397U
- UPC Number: 019532708366
- Model Number: DYNJ53984F
- UPC Number: 019348946948
- Model Number: DYNJ53984G
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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