Reported Oct 21, 2020 · Terminated
Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health" PROTEXIS" Latex Micro Surgical Gloves - Product…
Alcon Research, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Alcon Research, LLC · 9965 Buffalo Speedway · Houston, TX · 77054-1309
Is this the product you have?
- Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health" PROTEXIS" Latex
- Micro Surgical Gloves - Product Usageused by ophthalmic surgeons in a variety of ophthalmic surgeries
- Lot codes and dates
- Pak Number followed by the corresponding
- lot numbers are as follows
1,574 of 1,574 codes
0433-722359088H0433-722362546H10008-152364745H10391-042383902H10391-042388582H10391-042397523H10477-172346459H10477-182383904H1087-632353407H1087-642395495H11016-112350017H11311-072403959H11311-072406031H11345-082363773H11345-082363774H11345-082363775H11437-032362137H11437-032379506H11437-032385658H11437-032394132H11458-172370067H11458-172375171H11458-172390120H11458-172393525H11458-172400520H11786-012347153H11786-012380332H1179-432379382H1179-432384124H1179-432384125H
- Amount recalled
- 16,971 Paks
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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