The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin effects may occur. These may include irritation, erythema, or mild inflammation.
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: 1) PBCCGRSGD, UDI-DI: 10197106840085(each), 50197106840083(case), Lot Number: NGKU0957 ; 2) PB35GYBJC, UDI-DI: 10197106375723(each), 50197106375721(case), Lot Number: NGKU2052 ; 3) PGVMOTBB19, UDI-DI: 10198956264113(each), 50198956264111(case), Lot Number: NGKT2394 ; 4) PGVM07C26, UDI-DI: 10198956264434(each), 50198956264432(case), Lot Number: NGKT2394 ; 5) PGVM07C27, UDI-DI: 10198956292895(each), 50198956292893(case), Lot Number: NGKT2394 ; 6) PGV2LTNHN, UDI-DI: 10198956292499(each), 50198956292497(case), Lot Number: NGKV2390 ; 7) PGV2LTNHN, UDI-DI: 10198956292499(each), 50198956292497(case), Lot Number: NGKV3390 ; 8) PG15OT92A, UDI-DI: 10197106475041(each), 50197106475049(case), Lot Number: NGKW2883 ; 9) PG23MLNLD, UDI-DI: 10198956432024(each), 50198956432022(case), Lot Number: NGKU3969 ; 10) PG29GCPCK, UDI-DI: 10198956299207(each), 50198956299205(case), Lot Number: NGKU4716 ; 11) PG29GCPC3, UDI-DI: 10198956532496(each), 50198956532494(case), Lot Number: NGKU4716 ; 12) PG33LVMNC, UDI-DI: 10198956188358(each), 50198956188356(case), Lot Number: NGKU1994 ; 13) PG33LVMNC, UDI-DI: 10198956188358(each), 50198956188356(case), Lot Number: NGKU1994 ; 14) PG33LVMNC, UDI-DI: 10198956188358(each), 50198956188356(case), Lot Number: NGKU1994 ; 15) PG33LVMNC, UDI-DI: 10198956188358(each), 50198956188356(case), Lot Number: NGKU1994 ; 16) PG35HPBJK, UDI-DI: 10198956124110(each), 50198956124118(case), Lot Number: NGKU0856 ; 17) PG35HPBJK, UDI-DI: 10198956124110(each), 50198956124118(case), Lot Number: NGKU0957 ; 18) PG35HPBJK, UDI-DI: 10198956124110(each), 50198956124118(case), Lot Number: NGKU0957 ; 19) PG35HPBJK, UDI-DI: 10198956124110(each), 50198956124118(case), Lot Number: NGKU2052 ; 20) PG43MJEJD, UDI-DI: 10197106594261(each), 50197106594269(case), Lot Number: NGKW2883 ; 21) PG43MJEJD, UDI-DI: 10197106594261(each), 50197106594269(case), Lot Number: NGKW2883 ; 22) PVCGOTACF, UDI-DI: 10195594816469(each), 50195594816467(case), Lot Number: NGKV3487 ; 23) PVX4TAMYB, UDI-DI: 10197106892404(each), 50197106892402(case), Lot Number: NGKU4716 ; 24) PVX4TAMYB, UDI-DI: 10197106892404(each), 50197106892402(case), Lot Number: NGKU4716 ; 25) PVX4TAMYC, UDI-DI: 10198956329379(each), 50198956329377(case), Lot Number: NGKU4716 ; 26) PV23HEVAE, UDI-DI: 10198956062160(each), 50198956062168(case), Lot Number: NGKT2391 ; 27) PW35FABJE, UDI-DI: 10198956142282(each), 50198956142280(case), Lot Number: NGKT2394 ; 28) PW35FABJE, UDI-DI: 10198956142282(each), 50198956142280(case), Lot Number: NGKT2394 ; 29) PW35FABJE, UDI-DI: 10198956142282(each), 50198956142280(case), Lot Number: NGKT2394 ; 30) PW35FABJE, UDI-DI: 10198956142282(each), 50198956142280(case), Lot Number: NGKT2394 ; 31) SBA23RBHNG, UDI-DI: 10197106417577(each), 50197106417575(case), Lot Number: NGKU0129 ; 32) SBA23RBHNH, UDI-DI: 10198956332010(each), 50198956332018(case), Lot Number: NGKU0129
✅ What Should You Do?
1Contact your healthcare provider immediately to discuss this recall.
2Stop using the device if it is safe to do so, and contact your provider.
3Follow the manufacturer's remedy instructions provided in the recall notice.
4Report device problems to FDA MedWatch or call 1-800-FDA-1088.