MEDLINE INDUSTRIES, LP - Northfield: Medline brand medical procedure convenience kits, labeled as: a) NEURO PACK, REF DYNJ37909A; b) SHUNT PACK, REF DYNJ40040C

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: 51 units Lot/code info: a) REF DYNJ37909A, UDI/DI 40193489675451 (each), 10193489675450 (case), Lot Numbers: 24ABG035; b) REF DYNJ40040C, UDI/DI 40889942683971 (each), 10889942683970 (case), Lot Numbers: 23KBB863

UPC codes

40193489675451, 10193489675450, 40889942683971, 10889942683970

Source

Official record: FDA (Device enforcement) ↗

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