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CUSTOM-PAK OPHTHALMIC SURGERY PROCEDURE PACK (2017-10-10)
- Starting date:
- October 10, 2017
- Posting date:
- October 20, 2017
- 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-64904
Affected products
CUSTOM-PAK OPHTHALMIC SURGERY PROCEDURE PACK
Reason
Medtronic has informed Alcon that a recall is being conducted due to possible contamination with human blood caused by handling of the Covidien VISTEC X-Ray Detectable Sponges during the manufacturing process and prior to final packaging and ethylene oxide sterilization. Alcon used sponges from one of the affected lots to build custom packs.
Affected products
CUSTOM-PAK OPHTHALMIC SURGERY PROCEDURE PACK
Lot or serial number
- 2030393H
- 2033357H
- 2033369H
- 2033410H
- 2038808H
- 2039141H
- 2041240H
- 2041571H
Model or catalog number
- 14368-04
- 15328-01
- 17240-01
- 2732-58
Companies
- Manufacturer
-
Alcon Laboratories Inc.
6201 South Freeway
Fort Worth
Texas
UNITED STATES