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Glidesheath Slender Hydrophilic Coated Introducer Sheath
- Starting date:
- May 25, 2017
- Posting date:
- June 13, 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-63614
Reason
During an in-house investigation, an incomplete seal at the chevron end of the primary packaging was detected. Because the potential loss of package integrity may compromise the sterility of the product, Terumo Corporation has decided to remove all affected product from the field.
Affected products
Glidesheath Slender Hydrophilic Coated Introducer Sheath
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- RM*ES6J10HAT
- RM*RS6F10PA
- RM*RS7F10PA
- RM*RS7J16PA
Companies
- Manufacturer
-
Terumo Corporation
44-1, 2-CHOME, HATAGAYA, SHIBUYA-KU, TOKYO-TO
151-0072
JAPAN