Recall Z-0095-2021
Alcon Research, LLC · initiated August 24, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Pak Number followed by the corresponding lot numbers are as follows: 0433-72 2359088H 0433-72 2362546H 10008-15 2364745H 10391-04 2383902H 10391-04 2388582H 10391-04 2397523H 10477-17 2346459H 10477-18 2383904H 1087-63 2353407H 1087-64 2395495H 11016-11 2350017H 11311-07 2403959H 11311-07 2406031H 11345-08 2363773H 11345-08 2363774H 11345-08 2363775H 11437-03 2362137H 11437-03 2379506H 11437-03 2385658H 11437-03 2394132H 11458-17 2370067H 11458-17 2375171H 11458-17 2390120H 11458-17 2393525H 11458-17 2400520H 11786-01 2347153H 11786-01 2380332H 1179-43 2379382H 1179-43 2384124H 1179-43 2384125H 1179-43 2388444H 1179-43 2388445H 11876-18 2362142H 11876-18 2369176H 11876-18 2379510H 1231-57 2365132H 1231-57 2369489H 1231-57 2372302H 1231-57 2383379H 1231-57 2391174H 1231-57 2393089H 1231-57 2399904H 1231-57 2401798H 1231-57 2403559H 12732-05 2394138H 12736-09 2365968H 12736-09 2375271H 12736-09 2390575H 12736-09 2392097H 12736-09 2395160H 12878-13 2384211H 12878-13 2385672H 12896-09 2358037H 12896-09 2376070H 12896-09 2385542H 12896-09 2387051H 12896-09 2394141H 12896-09 2395582H 13152-08 2384214H 13193-11 2372672H 13193-11 2394902H 13194-12 2346890H 13194-13 2363370H 13194-13…
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-0095-2021
- Initiated
- August 24, 2020
- Terminated
- November 17, 2021
- Product code
- LRO – General Surgery Tray
- 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.
- Recalling firm
- Alcon Research, LLC, Houston, TX