Coseal Premix Surgical Sealant, Floseal Hemostatic Matrix & Hemopatch Bicarb (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-71375
Last updated: 2019-10-25
Affected Products
- Coseal Premix Surgical Sealant
- Floseal Hemostatic Matrix
- Hemopatch Bicarb
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. Coseal Premix Surgical Sealant
Lot or serial number
HA190767
Model or catalog number
934071
Companies
- Manufacturer
-
Baxter Healthcare Corporation
711 Park Ave.
Medina
14103
New York
UNITED STATES
B. Floseal Hemostatic Matrix
Lot or serial number
HA190743A
Model or catalog number
1505116
Companies
- Manufacturer
-
Baxter Healthcare Corporation
711 Park Ave.
Medina
14103
New York
UNITED STATES
C. Hemopatch Bicarb
Lot or serial number
LK19B221
Model or catalog number
1506256
Companies
- Manufacturer
-
Baxter Healthcare Corporation
711 Park Ave.
Medina
14103
New York
UNITED STATES