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FDA (Device enforcement)Recalled 2024-10-09class ii

MEDLINE INDUSTRIES, LP - Northfield: MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY-LF, REF CDS760059I; 2) GYN LAPAROSCOPY CDS #34-RF, REF CDS920099S; 3) GYN MAJOR, REF CDS980998L; 4) ROBOTIC

Hazard

Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.

Details from the source

Reason for recall: Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. Distribution: US Nationwide distribution. Quantity: 13057 units Lot/code info: 85OHD, 1) REF CDS760059I, UDI/DI 10195327009526 (each) 40195327009527 (case), Lot Numbers: 22KBT168, 22GBJ110, 22FBO228, 22FBN206, 23ABM526; 2) REF CDS920099S, UDI/DI 10195327140656 (each) 40195327140657 (case), Lot Numbers: 22EBA153, 23HBS831, 23GBT006, 23ABF835, 23ABE852, 23ABC459, 22IBE827, 22GBP098; 3) REF CDS980998L, UDI/DI 10193489232837 (each) 40193489232838 (case), Lot Numbers: 23HBS764, 24CBA346, 24BBO669; 4) REF CDS982128P, UDI/DI 10195327491659 (each) 40195327491650 (case), Lot Numbers: 23JBV057; 5) REF CDS984262N, UDI/DI 10195327241735 (each) 40195327241736 (case), Lot Numbers: 23ABN752, 23ABH001, 23CBU637, 23EBG216, 23FBL899; 6) REF CDS984900M, UDI/DI 10195327265670 (each) 40195327265671 (case), Lot Numbers: 23EBA735; 7) REF CDS984900N, UDI/DI 10195327448417 (each) 40195327448418 (case), Lot Numbers: 23JBT539, 24ABT539; 8) REF DYNJ0101304G, UDI/DI 10195327351663 (each) 40195327351664 (case), Lot Numbers: 23GDA822, 23CDA336; 9) REF DYNJ0347372J, UDI/DI 10195327555245 (each) 40195327555246 (case), Lot Numbers: 24CBN143, 24DBI923; 10) REF DYNJ17454N, UDI/DI 10195327491604 (each) 40195327491605 (case), Lot Numbers: 23JBR958; 11) REF DYNJ33592I, UDI/DI 10195327469559 (each) 40195327469550 (case), Lot Numbers: 23IDC293; 12) REF DYNJ38844N, UDI/DI 10195327243166 (each) 40195327243167 (case), Lot Numbers: 23DBB947, 23CBN366, 23EBW814, 23BBD619, 23DBI585; 13) REF DYNJ42792D, UDI/DI 10195327653514 (each) 40195327653515 (case), Lot Numbers: 24CBA980; 14) REF DYNJ43770L, UDI

UPC codes

10195327009526, 40195327009527, 10195327140656, 40195327140657, 10193489232837, 40193489232838, 10195327491659, 40195327491650, 10195327241735, 40195327241736, 10195327265670, 40195327265671, 10195327448417, 40195327448418, 10195327351663, 40195327351664, 10195327555245, 40195327555246, 10195327491604, 40195327491605, 10195327469559, 40195327469550, 10195327243166, 40195327243167, 10195327653514, 40195327653515, 10193489989991, 40193489989992, 10193489990133, 40193489990134, 10193489989892, 40193489989893, 10193489990157, 40193489990158, 10195327127619, 40195327127610, 10195327127626, 40195327127627, 10195327127695, 40195327127696

Source

Official record: FDA (Device enforcement)

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

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