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.
Recall
- Recall Number
- Z-0095-2021
- Event Number
- 86315
- Firm
- Alcon Research, LLC
- FEI Number
- 1000117501
- Product Code
- LRO
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- August 24, 2020
- Terminated
- November 17, 2021
- Address
- 9965 Buffalo, Speedway Houston, TX, 77054-1309
Description
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.
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.
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 present a potential risk of infection or cross patient-clinician exposure to body fluids. Customers were informed that Cardinal Health has received complaints regarding this issue, but that neither Cardinal or Alcon have received any reports of injury or harm. Customers are requested to review storage and usage locations to confirm whether they have any affected, listed in an attachment to the notification letter, in stock. Customers were warned that they may receive additional affected product, packaged and shipped before the recall was initiated. Customers were instructed that upon opening affected Paks, gloves should be removed, segregated and disposed of to prevent their use. Customers are requested to forward the notice to all departments and organizations affected, and fill out and return the Response Form via Fax or email to Alcon at Fax: 817-302-4337 or Email: Market.Actions@a lcon.com even if no product is remaining in stock. Customers were informed that their accounts will be credited to compensate for unused gloves, and that other components in the Alcon Custom Paks are unaffected and may be used. Customers with questions should contact customer service at 1 800 862 5266, or contact their Alcon Sales Representative.
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.
16,971 Paks