Medline Convenience Kits Recalled for Sterilization Calibration Issues
Medline is recalling multiple convenience kits used in catheterization labs and surgical procedures due to calibration issues with sterilization equipment that may affect sterility assurance. The affected kits were 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: This is an FDA Class II recall involving medical devices used in invasive procedures where compromised sterility assurance could result in patient infection or serious injury. Class II recalls with potential for serious patient harm are classified as Severe per the rubric.
Plain-English summary
Medline Industries, LP is recalling 6,961 units of multiple Medline Convenience Kits, including Angio Procedure Packs, Endo Kits, Angiography Packs, and related surgical procedure kits. These kits are used in medical procedures including angiography, endoscopy, biopsy, and general surgical applications.
The recall was initiated due to calibration issues identified in 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.
These kits have been distributed nationwide throughout the United States. Healthcare facilities and providers who have received these products should verify lot numbers and contact Medline for specific instructions regarding the affected units. The FDA has classified this as a Class II recall.
The recalled product
- Product
- Medline Convenience Kits: 1) ANGIO PROCEDURE PACK, Model Number:00-401824AA; 2) ENDO KIT W/SYRINGE, Model Number:DYKE1743; 3) BGMC ANGIOGRAPHY PACK-LF, Model Number:DYNJ0800934D; 4) GENERAL ENDO PACK-LF, Model Number:DYNJ0842873J; 5) ANGIO PROCEDURE PACK, Model…
- Manufacturer
- Medline Industries, LP
- Affected units
- 6,961
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) 00-401824AA
- UDI-DI: 10193489455885(each)
- 40193489455886(case)
- Lot Number: 23ABN008
- 2) 00-401824AA
- Lot Number: 23CBM469
- 3) 00-401824AA
- Lot Number: 23EBH500
- 4) 00-401824AA
- Lot Number: 23GBE369
- 5) 00-401824AA
- Lot Number: 23IBE051
- 6) 00-401824AA
- Lot Number: 23IBU695
- 7) 00-401824AA
- Lot Number: 23KBD600
- 8) 00-401824AA
- Lot Number: 23LBC152
- 9) 00-401824AA
- Lot Number: 24ABR800
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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