Health product recall

Pro-Vent Plus, Anaerobic Pulsator Plus, Pulsator Liquid Heparin, and Dry Pulsator Plus Arterial Blood Gas Sampling Kit (2018-06-26)

Starting date:
June 26, 2018
Posting date:
July 19, 2018
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-67262

Affected products

A. Pro-Vent Plus Arterial Blood Gas Sampling
B. Anaerobic Pulsator Plus Arterial Blood Sampling
C. Pulsator Liquid Heparin Arterial Blood Sampling Kits
D. Dry Pulsator Plus Arterial Blood Sampling Kit

Reason

Medline industries, Inc. (Medline) notified Smith’s Medical of a recall affecting specific lots of Medline Aplicare branded PVP-I Prep Pads, which were packaged within Smiths Medical Portex Pro-Vent and Pulsator Arterial Blood Sampling (ABS) kits.
Medline indicated that upon review of stability testing, it was found that these PVP-I Prep Pad products did not meet the specification for %povidone iodine at the 30 month time point (the product is currently labeled with a 36 month shelf life). Their product is marketed under the Tentative Final Monograph (TFM) for OTC healthcare antiseptic drug products - June 17, 1994. Healthcare antiseptics within the range of 5% - 10% povidone iodine are generally recognized as safe and effective. All stability results confirm this product is well within this range.

Affected products

A. Pro-Vent Plus Arterial Blood Gas Sampling

Lot or serial number

More than 1000 numbers, contact manufacturer.

Model or catalog number

4589P-1
4591P-1
4599P-1
4640P-1
4660P-1
4699P-1
G1671

Companies
Manufacturer

Smiths Medical Asd Inc.

10 Bowman Drive

Keene

03431

New Hampshire

UNITED STATES

B. Anaerobic Pulsator Plus Arterial Blood Sampling

Lot or serial number

More than 100 numbers, contact manufacturer.

Model or catalog number

4057NP-1
4067NP-1

Companies
Manufacturer

Smiths Medical Asd Inc.

10 Bowman Drive

Keene

03431

New Hampshire

UNITED STATES

C. Pulsator Liquid Heparin Arterial Blood Sampling Kits

Lot or serial number

More than 100 numbers, contact manufacturer.

Model or catalog number

4039-1

Companies
Manufacturer

Smiths Medical Asd Inc.

10 Bowman Drive

Keene

03431

New Hampshire

UNITED STATES

D. Dry Pulsator Plus Arterial Blood Sampling Kit

Lot or serial number

More than 100 numbers, contact manufacturer.

Model or catalog number

4044P-1
4084P-1

Companies
Manufacturer

Smiths Medical Asd Inc.

10 Bowman Drive

Keene

03431

New Hampshire

UNITED STATES