Peri-Guard & Dura-Guard (2019-09-23)
- Starting date:
- September 23, 2019
- Posting date:
- October 25, 2019
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-71373
Last updated: 2019-10-25
Affected Products
- Peri-Guard
- Dura-Guard
Reason
Baxter Canada made the decision to request return of certain cold chain orders due to the potential that the shipments may have gone outside of the validated pack-out parameters (pack-outs are validated for 2-8C for 48 hours). Baxter Canada was notified on Friday Sep 20 by our 3PL shipping provider that there was a delay at the processing location, which may cause the shipments to be delivered past the 48 hour limit. The orders could not be stopped and went out for delivery Monday Sep 23.
Affected products
A. Peri-Guard
Lot or serial number
- SP19E24-1375054
- SP19F06-1377738
- SP19F19-1380557
Model or catalog number
- PC-0404SN
- PC-0608SN
- PC-0814SN
Companies
- Manufacturer
-
Synovis Surgical Innovations
a Division of Synovis Life Technologies Inc.,
2575 University Avenue, suite 180
St-Paul
55114
Minnesota
UNITED STATES
B. Dura-Guard
Lot or serial number
SP19D12-1366638
Model or catalog number
DG-0814SN
Companies
- Manufacturer
-
Synovis Surgical Innovations
a Division of Synovis Life Technologies Inc.,
2575 University Avenue, suite 180
St-Paul
55114
Minnesota
UNITED STATES