Health product recall

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

  1. Peri-Guard
  2. 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