PlainRecalls
FDA Devices Moderate Class II Ongoing

Centurion EP LAB INSTRUMENT KIT, REF MNS10480; medical procedure convenience kit

Reported: October 30, 2024 Initiated: September 4, 2024 #Z-0149-2025

Product Description

Centurion EP LAB INSTRUMENT KIT, REF MNS10480; medical procedure convenience kit

Reason for Recall

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

Details

Units Affected
90 units
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Panama.
Location
Northfield, IL

Frequently Asked Questions

What product was recalled?
Centurion EP LAB INSTRUMENT KIT, REF MNS10480; medical procedure convenience kit. Recalled by MEDLINE INDUSTRIES, LP - Northfield. Units affected: 90 units.
Why was this product recalled?
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
Which agency issued this recall?
This recall was issued by the FDA Devices on October 30, 2024. Severity: Moderate. Recall number: Z-0149-2025.