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Health product recall

Vitrectomy Probes of Alcon (2015-06-04)

Starting date:
June 4, 2015
Posting date:
June 26, 2015
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Identification number:
RA-53948

Recalled Product

A.PROBE, POSTERIOR VIT

B.ACCURUS ACCUPAK

C.CUSTOM-PAK OPHTHALMIC SURGERY PROCEDURE PACK

Reason

Alcon is conducting a medical device recall for specific lots of its Vitrectomy Probes after an insufficient seal was discovered on the outside packaging, potentially affecting the sterility of the product.

Affected products

A.PROBE, POSTERIOR VIT

Lot or serial number

14014736X
14017452X
14020246X
14033830X

Model or catalog number

8065-7410-18                          8065-7508-21

Companies
Manufacturer
Alcon Laboratories Inc.
6201 South Freeway
Fort Worth
Texas
UNITED STATES

B.ACCURUS ACCUPAK

Lot or serial number

14012984X
14017451X
14020283X
14028555X

Model or catalog number

8065-8036-50

Companies
Manufacturer
Alcon Laboratories Inc.
6201 South Freeway
Fort Worth
Texas
UNITED STATES

C.CUSTOM-PAK OPHTHALMIC SURGERY PROCEDURE PACK

Lot or serial number

1686495H                        1700102H                      1730167H

Model or catalog number

5099-21

Companies
Manufacturer
Alcon Laboratories Inc.
6201 South Freeway
Fort Worth
Texas
UNITED STATES