Health product recall

CUSTOM-PAK OPHTHALMIC SURGERY PROCEDURE PACK (2020-08-25)

Starting date:
August 25, 2020
Posting date:
September 11, 2020
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-73897



Last updated:
2020-09-11

Affected Products

CUSTOM-PAK OPHTHALMIC SURGERY PROCEDURE PACK

Reason

Alcon has been notified by Cardinal Health, a third-party supplier, that they have initiated a voluntarily recall for specific production lots of Cardinal Health Protexis Latex Micro Surgical Gloves. Due to a degradation defect that was found on Cardinal Health Protexis Latex Micro Surgical Gloves that could lead to holes and donning tears at the folding area around the cuffs with the potential risk of infection or cross-patient (clinician) exposure to body fluids.

Affected products

CUSTOM-PAK OPHTHALMIC SURGERY PROCEDURE PACK

Lot or serial number
  • 2353346H
  • 2355860H
  • 2365788H
  • 2373226H
  • 2391522H
  • 2396743H
Model or catalog number
  • 14713-04
  • 18588-01
Companies
Manufacturer

Alcon Laboratories Inc.

6201 South Fwy

Fort Worth

76134

UNITED STATES