Medline Convenience Kits Recalled Over Sterilization Calibration Issues
Medline is recalling three models of medical convenience kits (central line, LVAD driveline, and surgical oncology) distributed nationwide due to calibration issues in sterilization equipment that may have reduced sterility assurance.
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 sterile medical devices with a potential mechanism of harm (reduced sterility assurance), but the source text does not report any confirmed illnesses, injuries, or hospitalizations. Per the rubric, Class II recalls without reported adverse events where there is a theoretical risk of harm score as High (3).
Plain-English summary
Medline Industries, LP is recalling 1,056 units of three convenience kit models: the Central Line Universal Insertion Kit (Model CVI3780), LVAD Driveline Tray (Model DM1035), and Surgical Oncology Central Venous Insertion Kit (Model DYKMBNDL43). The kits were distributed worldwide with US nationwide distribution.
Medline identified calibration issues in the equipment used to sterilize and package these devices. While all products were exposed to validated sterilization and packaging cycles, the calibration issues have the potential to compromise the sterility assurance level (SAL) of the recalled products.
Healthcare facilities and providers who received these kits should stop using the affected lot numbers and contact Medline or their authorized distributor for instructions on return or replacement. Lot numbers affected include multiple batches across all three product models.
The recalled product
- Product
- Medline Convenience Kits: 1) CENTRAL LINE UNIVERSAL INSERTI, Model Number: CVI3780; 2) LVAD DRIVELINE TRAY, Model Number: DM1035; 3) KIT SURG ONC INSERT CENT.VENOU, Model Number: DYKMBNDL43
- Manufacturer
- Medline Industries, LP
- Affected units
- 1,056
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)
- 1) CVI3780
- UDI-DI: 10193489434866(each)
- 40193489434867(case)
- Lot Number: 23KBO637
- 2) CVI3780
- Lot Number: 24ABC276
- 3) DM1035
- UDI-DI: 10193489442755(each)
- 40193489442756(case)
- Lot Number: 21BBN221
- 4) DYKMBNDL43
- UDI-DI: 10193489478891(each)
- 40193489478892(case)
- Lot Number: 21ABJ003
- 5) DYKMBNDL43
- Lot Number: 21ABO838
- 6) DYKMBNDL43
- Lot Number: 21DBD662
- 7) DYKMBNDL43
- Lot Number: 21IBJ337
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 42 recalled by Medline Industries, LP 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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