Medline Convenience Kits recalled due to sterilization calibration issues
Medline Industries is recalling multiple convenience kits used in surgical and biopsy procedures due to calibration issues with sterilization equipment that may affect sterility assurance. The recall affects 4,064 units distributed nationwide.
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 for sterile medical devices with a theoretical risk of compromised sterility assurance. No illnesses or injuries have been reported, but the potential impact on sterility of surgical and biopsy instruments represents a risk-of-harm scenario meeting the High severity threshold.
Plain-English summary
Medline Industries, LP is recalling 13 models of Medline Convenience Kits, including surgical oncology kits, biopsy trays, and specialized packs. The kits are used in various surgical and diagnostic procedures including breast surgery, exploratory laparoscopy, and biopsies of multiple organs.
Medline identified calibration issues with the equipment used to sterilize and package these devices. Although all products were exposed to validated sterilization and packaging cycles, the calibration issues have the potential to impact the sterility assurance level (SAL) of the recalled products.
The recall affects 4,064 units with nationwide distribution in the United States. Multiple lot numbers across the affected models are included in this recall. Healthcare facilities and providers who have received these products should contact Medline Industries for instructions on handling the recalled devices.
The recalled product
- Product
- Medline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST, Model Number:DYKMBNDL84A; 2) KIT SURG ONC EXPLORATORY LAP, Model Number:DYKMBNDL87A; 3) CT BIOPSY TRAY, Model Number:DYNDH1143C; 4) BIOPSY SPECIALS PACK, Model Number:DYNDH1873; 5) BIOPSY SPECIALS PACK, Model…
- Manufacturer
- Medline Industries, LP
- Affected units
- 4,064
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) DYKMBNDL84A
- UDI-DI: 10195327240486(each)
- 40195327240487(case)
- Lot Number: 22IBQ267
- 2) DYKMBNDL84A
- Lot Number: 22IBU924
- 3) DYKMBNDL84A
- Lot Number: 23ABK216
- 4) DYKMBNDL87A
- UDI-DI: 10195327240479(each)
- 40195327240470(case)
- Lot Number: 22LBK913
- 5) DYKMBNDL87A
- Lot Number: 22LBM302
- 6) DYKMBNDL87A
- Lot Number: 23ABU170
- 7) DYKMBNDL87A
- Lot Number: 23CBC364
- 8) DYKMBNDL87A
- Lot Number: 23CBL439
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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