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FDA (Device enforcement)Recalled 2024-09-04class ii

MEDLINE INDUSTRIES, LP - Northfield: Centurion EP LAB INSTRUMENT KIT, REF MNS10480; medical procedure convenience kit

Hazard

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 from the source

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. Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Panama. Quantity: 90 units Lot/code info: UDI/DI 40653160307816 (each), 10653160307815 (case), Lot Numbers: 23LBK889

UPC codes

40653160307816, 10653160307815

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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