FDA recall Z-0095-2021

Alcon Research, LLC · Class II · device

Product

Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health" PROTEXIS" Latex Micro Surgical Gloves - Product Usage: used by ophthalmic surgeons in a variety of ophthalmic surgeries.

Reason for recall

The third-party brand latex micro surgical gloves packaged within specific custom packs may have a degradation defect that could lead to holes and donning tears at the folding area around the cuffs. This could increase the potential risk of infection or cross-patient (clinician) exposure to body fluids.

Distribution

U.S. Nationwide distribution including in the states of AK, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, MN, MO, NE, NJ, NV, NY, OK, PA, TN, TX, UT, WA, WV.

Key facts

Status
Terminated
Initiation date
2020-08-24
Report date
2020-10-21
Termination date
2021-11-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Houston, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0095-2021