Z-1373-2022 Class II Ongoing
FDA device recall Z-1373-2022 was initiated by Alcon Research, LLC on Jun 9, 2022 and is designated Class II. Reason for recall: Due to latex gloves being include in Custom Pak. Kits are supposed to include non-latex gloves. The recall status is ongoing. Affected quantity: 320 kits.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 20, 2022
- Initiation Date
- Jun 9, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 320 kits
Product Description
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 NOVAMED EYE SURG CTR 11802-07 14LLME GANS BASIC PACK NOVAMED EYE SURG CTR 14429-07 14HPW3 DR SIEMINSKI CATARACT W NY CTR/AMB SVCS
Reason for Recall
Due to latex gloves being include in Custom Pak. Kits are supposed to include non-latex gloves.
Distribution Pattern
U.S.: AZ, CA, MO, and NY O.U.S.: None
Code Information
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1373-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026