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