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Percutaneous Sheath Introducer Kits with Silk Sutures (2014-05-01)
- Starting date:
- May 1, 2014
- Posting date:
- May 8, 2014
- 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-39405
Recalled Products
A. Percutaneous Sheath Introducer Kits with Silk Sutures
B. Percutaneous Sheath Introducer Sets
Reason
Arrow is recalling the products referenced above due to dilator tip damage noted during internal inspection of the percutaneous sheath introducer kits. Dilator tip damage has the potential to result in vessel damage. There are no reported related illnesses or injuries from the related device.
Affected products
A. Percutaneous Sheath Introducer Kits with Silk Sutures
Lot or serial number
23F13G0400
Model or catalog number
AK-09903-J
Companies
- Manufacturer
-
Arrow International, Inc.
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES
B. Percutaneous Sheath Introducer Sets
Lot or serial number
RF3064710
RF3064915
Model or catalog number
SI-09903-E
Companies
- Manufacturer
-
Arrow International, Inc.
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES