Medline Convenience Kits sterilization and packaging calibration issues recalled
Medline Industries is recalling multiple Convenience Kit models used in cardiac, vascular, and surgical procedures due to calibration issues with sterilization and packaging equipment that could impact sterility assurance. Approximately 39,341 units distributed worldwide may be affected.
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 medical device recall involving sterile surgical/cardiac procedure kits where sterilization assurance is compromised. Although no illnesses or injuries are reported in the source text, the potential loss of sterility assurance on high-risk medical devices used in invasive procedures meets the High severity threshold per the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling 57 model numbers of Medline Convenience Kits distributed nationwide and worldwide. The kits are used in cardiac catheterization, angiography, endovascular, and surgical oncology procedures. The recall affects approximately 39,341 units.
Medline identified issues related to calibration of equipment used to sterilize and package the devices. All products were exposed to validated sterilization and packaging cycles; however, the calibration issues have the potential to impact the sterility assurance level (SAL) of the recalled products.
Healthcare facilities that received affected Medline Convenience Kits should contact Medline Industries for instructions regarding use of recalled inventory. The FDA classified this as a Class II medical device recall.
The recalled product
- Product
- Medline Convenience Kits: 1) ANGIO PROCEDURE PACK, Model Number:00-401824AB; 2) OR ARTERIOGRAM, Model Number:CDS985094F; 3) INTRAVASOR CATH KIT, Model Number:DYK1060193I; 4) KIT SURG ONC LAP DIAG/CV CATH, Model Number:DYKMBNDL153; 5) KIT ACES INSERT PERCUTANEOUS T…
- Manufacturer
- Medline Industries, LP
- Affected units
- 39,341
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) 00-401824AB
- UDI-DI: 10198459089169(each)
- 40198459089160(case)
- Lot Number: 24IBQ637
- 2) 00-401824AB
- Lot Number: 24KBF279
- 3) 00-401824AB
- Lot Number: 24LBF132
- 4) 00-401824AB
- Lot Number: 25CBJ807
- 5) 00-401824AB
- Lot Number: 25DBO471
- 6) 00-401824AB
- Lot Number: 25GBK506
- 7) CDS985094F
- UDI-DI: 10195327657642(each)
- 40195327657643(case)
- Lot Number: 25AMG933
- 8) DYK1060193I
- UDI-DI: 10884389871737(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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