Alcon Custom Pak Surgical Procedure Packs recalled for incorrect latex gloves
Alcon has recalled 320 kits of Custom Pak Surgical Procedure Packs distributed across Arizona, California, Missouri, and New York because they contain latex gloves instead of the specified non-latex gloves, creating an allergen hazard for sensitive patients.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The FDA classified this as a Class II recall involving allergen mislabeling of latex, a common and serious allergen in surgical contexts. Although no illnesses or injuries have been reported, the hazard poses significant risk to latex-sensitive patients.
Plain-English summary
Alcon Research, LLC has recalled 320 kits of Custom Pak Surgical Procedure Packs because they contain latex gloves instead of the specified non-latex gloves. This creates an allergen hazard for patients with latex sensitivity, particularly in surgical settings where direct skin contact would occur.
The affected kits were distributed in the United States to surgical facilities in Arizona, California, Missouri, and New York. They include multiple lot and batch numbers with specific UDI codes.
Healthcare facilities that received these kits should discontinue use and contact Alcon or their surgical supply vendor for replacement non-latex versions. Patients with known latex allergies should inform their surgical team before procedures to ensure appropriate precautions are taken.
The recalled product
- Product
- 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…
- Manufacturer
- Alcon Research, LLC
- Hazard
- Affected units
- 320
Distribution
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