MEDLINE INDUSTRIES, LP - Northfield: Centurion brand, medical procedure convenience kits, labeled as: a) FLOOR - UMBILICAL CUT DOWN TRA, b) PLASTICS SUTURE TRAY

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: 168 units Lot/code info: a) UDI/DI 40653160270929 (each), 10653160270928 (case), Lot Numbers: 23LBO858; b) UDI/DI 40653160284346 (each), 10653160284345 (case), Lot Numbers: 23LBL653

UPC codes

40653160270929, 10653160270928, 40653160284346, 10653160284345

Source

Official record: FDA (Device enforcement) ↗

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