Recall Z-0095-2021 ยท LRO General Surgery Tray
Alcon Research, LLC
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.
| Date | Aug 24, 2020 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | Alcon sent their customers an Urgent Medical Device Advisory Letter via Fed-Ex overnight mail beginning on August 24, 2020. The letter notifies customers that Alcon has been informed by Cardinal Health that they have initiated a voluntary recall for specific production lots of Cardinal Health Protexis Latex Micro Surgical Gloves. Customers were informed of the following: records show their facility received Alcon Custom Pak(s) with the affected surgical gloves; the gloves may have a degradation defect which could lead to holes and donning tears around the cuff of the gloves; and that this may |
| Quantity | 16,971 Paks |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K880961 | ALCON SURGICAL PROCEDURE PACKS Alcon Laboratories, Apr 29, 1988 |