MEDLINE INDUSTRIES, LP - Northfield: Medline brand medical procedure convenience kits, labeled as: a) CONE BIOPSY PACK, REF DYNJ17534L; b) BIOPSY TRAY, REF DYNJ43076A; c) LOU LOOP RECORDER PACK, REF D

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: 2,426 units Lot/code info: a) REF DYNJ17534L, UDI/DI 40195327258253 (each), 10195327258252 (case), Lot Numbers: 23KBF936; b) REF DYNJ43076A, UDI/DI 40195327080625 (each), 10195327080624 (case), Lot Numbers: 23LBI584; c) REF DYNJ49404C, UDI/DI 40195327395453 (each), 10195327395452 (case), Lot Numbers: 23LBP833; d) REF DYNJ52666C, UDI/DI 40193489452144 (each), 10193489452143 (case), Lot Numbers: 23LBN740; e) REF DYNJ61130B, UDI/DI 40195327054589 (each), 10195327054588 (case), Lot Numbers: 23LBP401; f) REF DYNJ63165B, UDI/DI 40193489461580 (each), 10193489461589 (case), Lot Numbers: 23KBD517; g) REF DYNJ63575A, UDI/DI 40193489429337 (each), 10193489429336 (case), Lot Numbers: 23LBR787; h) REF DYNJ66347A, UDI/DI 40193489884716 (each), 10193489884715 (case), Lot Numbers: 24ABA444; i) REF DYNJ67926B, UDI/DI 40195327519514 (each), 10195327519513 (case), Lot Numbers: 23LBL347; j) REF DYNJ68261B, UDI/DI 40195327513369 (each), 10195327513368 (case), Lot Numbers: 24ABA492; k) REF DYNJ68393A, UDI/DI 40193489939997 (each), 10193489939996 (case), Lot Numbers: 23LBL431; l) REF DYNJ84129, UDI/DI 40195327334544 (each), 10195327334543 (case), Lot Numbers: 23KBB926

UPC codes

40195327258253, 10195327258252, 40195327080625, 10195327080624, 40195327395453, 10195327395452, 40193489452144, 10193489452143, 40195327054589, 10195327054588, 40193489461580, 10193489461589, 40193489429337, 10193489429336, 40193489884716, 10193489884715, 40195327519514, 10195327519513, 40195327513369, 10195327513368, 40193489939997, 10193489939996, 40195327334544, 10195327334543

Source

Official record: FDA (Device enforcement) ↗

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