Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, ASLMC CRANIOTOMY , Catalog Number: PNCGCNAUM; 2) KIT, ORP MAJOR SPINE , Catalog Number: PNHDFSVCI; 3) KIT,ORP NEURO TRAUMA , Catalog Number: PNHDOTVCQ; 4) KIT, CRANIOTOMY PRESBYTERIAN , Catalog Number: PNV
Check against the official notice below — it lists the full affected range.
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.
Reason for recall: 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. Distribution: US Nationwide distribution. Quantity: 645 units Lot/code info: 1) PNCGCNAUM, UDI-DI: 10197106894316(each), 50197106894314(case), Lot Number: NGKT2391 ; 2) PNCGCNAUM, UDI-DI: 10197106894316(each), 50197106894314(case), Lot Number: NGKT2455 ; 3) PNHDFSVCI, UDI-DI: 10198956143470(each), 50198956143478(case), Lot Number: NGKU1022 ; 4) PNHDFSVCI, UDI-DI: 10198956143470(each), 50198956143478(case), Lot Number: NGKU1022 ; 5) PNHDOTVCQ, UDI-DI: 10198956143777(each), 50198956143775(case), Lot Number: NGKU1022 ; 6) PNHDOTVCQ, UDI-DI: 10198956143777(each), 50198956143775(case), Lot Number: NGKU1022 ; 7) PNHDOTVCQ, UDI-DI: 10198956143777(each), 50198956143775(case), Lot Number: NGKU1022 ; 8) PNV20101L, UDI-DI: 10198956285217(each), 50198956285215(case), Lot Number: NGKV3390 ; 9) PNV20101L, UDI-DI: 10198956285217(each), 50198956285215(case), Lot Number: NGKV2390 ; 10) PNV20101L, UDI-DI: 10198956285217(each), 50198956285215(case), Lot Number: NGKV2390 ; 11) PN15LSRMH, UDI-DI: 10198956341692(each), 50198956341690(case), Lot Number: NGKW3769 ; 12) SNECGLFABB, UDI-DI: 10197106881675(each), 50197106881673(case), Lot Number: NGKU0856 ; 13) SNEOCGSLHP, UDI-DI: 10198956233430(each), 50198956233438(case), Lot Number: NGKW3769 ; 14) SNEOCGSLHP, UDI-DI: 10198956233430(each), 50198956233438(case), Lot Number: NGKW3769 ; 15) SNEOCGSL20, UDI-DI: 10198956305762(each), 50198956305760(case), Lot Number: NGKW0682 ; 16) SNEOCGSL20, UDI-DI: 10198956305762(each), 50198956305760(case), Lot Number: NGKW3769
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.