Reconstitution Device & PD Empty Bag System (2021-06-26)
- Starting date:
- June 26, 2021
- Posting date:
- June 30, 2021
- 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-75917
Last updated:
2021-06-30
Affected Products
A. RECONSTITUTION DEVICE
B. PD 3L EMPTY BAG SYSTEM
Reason
Baxter Corporation was informed by one of our third-party sterilization providers that certain lots of Medication Delivery and Renal Care products may not have been properly sterilized, or adequate documentation of sterilization was not provided to Baxter.
Affected products
A. RECONSTITUTION DEVICE
Lot or serial number
16G22V239
16H01V523
17H03V526
18G02V160
18G05V161
Model or catalog number
NGB8064M
Companies
- Manufacturer
-
Baxter Healthcare SA
PO BOX 8010
Zurich
8010
SWITZERLAND
B. PD 3L EMPTY BAG SYSTEM
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
XMC4284
Companies
- Manufacturer
-
Baxter Healthcare SA
Zurich
8010
SWITZERLAND