Origen O-Wrap System (2019-08-19)
- Starting date:
- August 19, 2019
- Posting date:
- December 13, 2019
- 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-71855
Last updated: 2019-12-13
Affecetd Products
- Origen O-Wrap
- TissueVault Tissue Freezing Bags
- DMSO-Resistant Bag Spike With Needle-Free Injection Port
Reason
Unsealed sterile barrier pouch was made on a device packaged in a double sterile barrier system.
Affected products
-
Origen O-Wrap
Lot or serial number
U20630
Model or catalog number
OW1430
Companies
- Manufacturer
-
ORIGEN BIOMEDICAL INC.
7000 BURLESON ROAD, BUILDING D
AUSTIN
78744
Texas
UNITED STATES
B. TissueVault Tissue Freezing Bags
Lot or serial number
U20592
Model or catalog number
TV0918
Companies
- Manufacturer
-
ORIGEN BIOMEDICAL INC.
7000 BURLESON ROAD, BUILDING D
AUSTIN
78744
Texas
UNITED STATES
C. DMSO-Resistant Bag Spike With Needle-Free Injection Port
Lot or serial number
U20617
U20683
U20711
U20725
Model or catalog number
CBS
Companies
- Manufacturer
-
ORIGEN BIOMEDICAL INC.
7000 BURLESON ROAD, BUILDING D
AUSTIN
78744
Texas
UNITED STATES