Health product recall

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