Health product recall

ONE-LINK Needle-free System (2019-12-17)

Starting date:
December 17, 2019
Posting date:
January 6, 2020
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-72023



Last updated: 2020-01-07

Affected Products

A. Clearlink System Continu-Flo Administration Sets

B. Clearlink System Continu-Flo Administration Sets

C. ONE-LINK Needle-free IV Connectors

D. ONE-LINK Needle-free IV Connectors

E. ONE-LINK Needle-free IV Connectors

F. ONE-LINK Needle-free IV Connectors

G. ONE-LINK Needle-free IV Connectors

H. ONE-LINK Needle-free IV Connectors

I. ONE-LINK Needle-free IV Connectors

J. ONE-LINK Needle-free IV Connectors

K. Clearlink System Continu-Flo Administration Sets

Reason

Baxter Corporation has received customer complaints indicating that increased force may be required to securely connect the clearlink system continu-flo administration sets with one-link needle-free connectors listed.

Affected products

A. Clearlink System Continu-Flo Administration Sets

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

2C8541

Companies
Manufacturer

Baxter Healthcare Corporation

1 Baxter Parkway

Deerfield

60015

Illinois

UNITED STATES


B. Clearlink System Continu-Flo Administration Sets

Lot or serial number

More than 10 numbers, contact manufacturer. 

Model or catalog number

2C8541

Companies
Manufacturer

Baxter Healthcare Corporation

1 Baxter Parkway

Deerfield

60015

Illinois

UNITED STATES


C. ONE-LINK Needle-free IV Connectors

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

7N8399

Companies
Manufacturer

Baxter Healthcare Corporation

1 Baxter Parkway

Deerfield

60015

Illinois

UNITED STATES


D. ONE-LINK Needle-free IV Connectors

Lot or serial number

More than 10 numbers, contact manufacturer. 

Model or catalog number

7N8377

Companies
Manufacturer

Baxter Healthcare Corporation

1 Baxter Parkway

Deerfield

60015

Illinois

UNITED STATES


E. ONE-LINK Needle-free IV Connectors

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

7N8371

Companies
Manufacturer

Baxter Healthcare Corporation

1 Baxter Parkway

Deerfield

60015

Illinois

UNITED STATES


F. ONE-LINK Needle-free IV Connectors

Lot or serial number

More than 10 numbers, contact manufacturer. 

Model or catalog number

7N8300

7N8310

Companies
Manufacturer

Baxter Healthcare Corporation

1 Baxter Parkway

Deerfield

60015

Illinois

UNITED STATES


G. ONE-LINK Needle-free IV Connectors

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

7N8378

Companies
Manufacturer

Baxter Healthcare Corporation

1 Baxter Parkway

Deerfield

60015

Illinois

UNITED STATES


H. ONE-LINK Needle-free IV Connectors

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

7N8390

Companies
Manufacturer

Baxter Healthcare Corporation

1 Baxter Parkway

Deerfield

60015

Illinois

UNITED STATES


I. ONE-LINK Needle-free IV Connectors

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

7N8391

Companies
Manufacturer

Baxter Healthcare Corporation

1 Baxter Parkway

Deerfield

60015

Illinois

UNITED STATES


J. ONE-LINK Needle-free IV Connectors

Lot or serial number

More than 10 numbers, contact manufacturer. 

Model or catalog number

7N8301

Companies
Manufacturer

Baxter Healthcare Corporation

1 Baxter Parkway

Deerfield

60015

Illinois

UNITED STATES


K. Clearlink System Continu-Flo Administration Sets

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

2C8541

Companies
Manufacturer

Baxter Healthcare Corporation

1 Baxter Parkway

Deerfield

60015

Illinois

UNITED STATES