Health product recall

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

  1. Origen O-Wrap
  2. TissueVault Tissue Freezing Bags
  3. 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

  1. 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