Medline Convenience Kits recalled for potential sterility assurance defects
Medline Industries is recalling six models of medical device convenience kits due to calibration issues with sterilization and packaging equipment that may have reduced sterility assurance levels. The recall affects 553 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as Class II. The hazard involves potential compromise of sterility assurance in invasive medical devices (PICC lines, arthroscopy trays, percutaneous lines, NICU equipment), which pose a direct risk of serious infection if sterility is breached. No illnesses are reported, but the nature of the affected devices and the underlying hazard elevates this to Severe.
Plain-English summary
Medline Industries, LP is recalling six models of medical device convenience kits: PICC Catheter Insertion Tray (Model CVI4300), OSC Sherman Knee Arthro Basic (Model DYKM1977C), Kit ACES Insert PEG (Models DYKMBNDL130 and DYKMBNDL130A), Kit ACES Insert Percutaneous T (Model DYKMBNDL4), and NICU Line Change Tray (Model LC295). A total of 553 units have been distributed nationwide.
The recall was initiated because of calibration issues identified in the equipment used to sterilize and package these devices. While all products were exposed to validated sterilization and packaging cycles, the calibration defects have the potential to impact the sterility assurance level (SAL) of the recalled products.
Patients or healthcare providers who have received or are using any of the affected kits should contact Medline Industries, LP for further instructions regarding the recall. Healthcare facilities should review their inventories and quarantine any units matching the affected lot numbers.
The recalled product
- Product
- Medline Convenience Kits: 1) PICC CATHETER INSERTION TRAY, Model Number: CVI4300; 2) OSC SHERMAN KNEE ARTHRO BASIC, Model Number: DYKM1977C; 3) KIT ACES INSERT PEG, Model Number: DYKMBNDL130; 4) KIT ACES INSERT PEG, Model Number: DYKMBNDL130A; 5) KIT ACES INSERT…
- Manufacturer
- Medline Industries, LP
- Affected units
- 553
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) CVI4300
- UDI-DI: 10653160294313(each)
- 653160294316(case)
- Lot Number: 2020120950
- 2) DYKM1977C
- UDI-DI: 10653160381105(each)
- 653160381108(case)
- Lot Number: 2024110190
- 3) DYKMBNDL130
- UDI-DI: 10193489479027(each)
- 40193489479028(case)
- Lot Number: 21ABC197
- 4) DYKMBNDL130
- Lot Number: 21ABJ543
- 5) DYKMBNDL130
- Lot Number: 21BBB580
- 6) DYKMBNDL130A
- UDI-DI: 10193489829594(each)
- 40193489829595(case)
- Lot Number: 21CLA391
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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