Medline Centurion EP LAB INSTRUMENT KIT Recalled for Potential Sterility Compromise
Medline Industries is recalling 90 units of Centurion EP LAB INSTRUMENT KIT convenience kits from lot 23LBK889. The kits may contain non-sterile product if the breather pouch vendor seal is opened or compromised.
What this means for you
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 involving potential sterility compromise in medical devices. No illnesses or injuries have been reported, making the hazard theoretical. The recall meets the rubric criterion for High severity as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling 90 units of the Centurion EP LAB INSTRUMENT KIT (REF MNS10480), a medical procedure convenience kit. The affected kits are from lot 23LBK889 and were packaged in breather pouches from lot 323080002. The kits were distributed worldwide to the US, Canada, and Panama.
The issue involves breather pouches from lot 323080002, which may allow non-sterile product if the vendor seal is opened or unsealed during distribution or storage. Using a non-sterile medical procedure kit poses a potential risk during medical procedures.
Customers who have received affected kits should verify that the vendor seal on the breather pouch remains intact. Do not use the product if the seal has been compromised or opened. Contact Medline Industries, LP for further guidance and instructions regarding affected units.
The recalled product
- Product
- Centurion EP LAB INSTRUMENT KIT, REF MNS10480; medical procedure convenience kit
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- Affected units
- 90
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 (3)
- UDI/DI 40653160307816 (each)
- 10653160307815 (case)
- Lot Numbers: 23LBK889
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 33 recalled by MEDLINE INDUSTRIES, LP - Northfield 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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