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