Alcon Custom Pak Surgical Procedure Pack: 16998-11 2519351H SALAHUDDIN 2.4 PACK FRESNO SURGICAL HOSP 18392-03 14HDFF CATARACT SWAGEL WOOTTON EYE INSTITUTE 18527-03 14JM57 DOSS CATARACT ALLIANCE EYE SURG PARTNERS 11802-07 14KFAF GANS BASIC PACK NOVAMED EYE SURG CTR 11802-07 14LTRW GANS BASIC PACK NOV
Check against the official notice below — it lists the full affected range.
Alcon Research, LLC is recalling 320 Custom Pak Surgical Procedure Packs distributed to hospitals in Arizona, California, Missouri, and New York. The kits were supposed to contain non-latex gloves but instead included latex gloves, creating a potential hazard for patients or healthcare workers with latex allergies or sensitivities.
The affected kits have specific lot and batch numbers that can be identified by their UDI codes. The source document does not specify what actions affected consumers or healthcare facilities should take regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Due to latex gloves being include in Custom Pak. Kits are supposed to include non-latex gloves.
Reason for recall: Due to latex gloves being include in Custom Pak. Kits are supposed to include non-latex gloves. Distribution: U.S.: AZ, CA, MO, and NY O.U.S.: None Quantity: 320 kits Lot/code info: Pak #/Batch # / UDI Code 16998-11 / 2519351H / (01)10380651677385(10)2519351H(17)230331(30)3 18392-03 / 14HDFF / (01)10380651665238(10)14HDFF(17)221231(30)4 18527-03 / 14JM57 / (01)10380651684406(10)14JM57(17)240630(30)5 11802-07 / 14KFAF / (01)10380653423096(10)14KFAF(17)240430(30)5 11802-07 / 14LTRW / (01)10380653423096(10)14LTRW(17)240430(30)5 11802-07 / 14LLME / (01)10380653423096(10)14LLME(17)240430(30)5 14429-07 / 14HPW3 / (01)10380651666433(10)14HPW3(17)240229(30)6
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.