Medline Convenience Kits Recalled Due to Sterilization Equipment Calibration Issues
Medline Industries is recalling multiple Convenience Kits nationwide because sterilization equipment calibration issues may have compromised the sterility assurance level of the products, despite exposure to validated sterilization cycles.
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: FDA Class II classification combined with a potential impact to sterility assurance level of surgical/medical convenience kits—a risk-of-harm product where no illnesses or injuries have been reported—meets the threshold for a High severity rating.
Plain-English summary
Medline Industries, LP is recalling 1516 units of various Medline Convenience Kits, including CVC PACK, TOTE models for hand repair, capsulotomy, hip arthroscopy, knee arthroscopy, wrist arthroscopy, block blood patch, lumpectomy, liposuction procedures, and chest tube supplies. The kits are distributed nationwide and worldwide.
Medline has identified calibration issues with equipment used to sterilize and package the devices. Although all products were exposed to validated sterilization and packaging cycles, the calibration problems have the potential to impact the sterility assurance level (SAL) of the recalled products.
Consumers or healthcare facilities that have received these Convenience Kits should contact Medline Industries for instructions on return or replacement of the affected products. The recall includes multiple lot numbers across the product line, which are specified in the detailed product code information.
The recalled product
- Product
- Medline Convenience Kits: 1) CVC PACK, Model Number: CVI4500A; 2) TOTE KAMAL OSC HAND REPAIR, Model Number: DYKM1730A; 3) TOTE CHANGE OSC HAND REPAIR, Model Number: DYKM1751A; 4) TOTE SB NGUYEN CAPSULOTOMY, Model Number: DYKM1756A; 5) TOTE MOMENI SB CAPSULOTOMY REC…
- Manufacturer
- Medline Industries, LP
- Affected units
- 1,516
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) CVI4500A
- UDI-DI: 10653160327646(each)
- 653160327649(case)
- Lot Number: 2020121550
- 2) DYKM1730A
- UDI-DI: 10193489111019(each)
- 20193489111016(case)
- Lot Number: 2024030690
- 3) DYKM1730A
- Lot Number: 2024052290
- 4) DYKM1730A
- Lot Number: 2024060590
- 5) DYKM1730A
- Lot Number: 2025012890
- 6) DYKM1751A
- UDI-DI: 10193489111002(each)
- 20193489111009(case)
- Lot Number: 2023121190
- 7) DYKM1756A
- UDI-DI: 10193489190250(each)
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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