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ARROW SUPER ARROW-FLEX PERCUTANEOUS SHEATH INTRODUCER SET (2016-01-21)
- Starting date:
- January 21, 2016
- Posting date:
- February 8, 2016
- 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-57036
Affected Products
ARROW SUPER ARROW-FLEX PERCUTANEOUS SHEATH INTRODUCER SET
Reason
Arrow has issued a recall for these products due to potential packaging damage. Therefore, the sterility of the product cannot be guaranteed. If a non-sterile product is used, there is potential for infection to occur. No patient injuries have been reported related to this issue.
Affected products
ARROW SUPER ARROW-FLEX PERCUTANEOUS SHEATH INTRODUCER SET
Lot or serial number
More than 1000 numbers, contact manufacturer
Model or catalog number
- CL-07035
- CL-07635
- CL-07735
- CL-07835
Companies
- Manufacturer
-
Arrow International Inc.
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES