Recall Z-0109-2013— Westmed Inc
Class II · Terminated
Class II FDA medical device recall by Westmed Inc, initiated 2011-01-18, terminated 2012-10-22. FDA's recall record names no specific 510(k) clearance for this event. Product: Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 3 cc, w/Crickett 23g x 1" A Needle, 25U Balanced Heparin, part number: 3383-95, 3344-95, 3353-95. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations.. Reason: Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants..
- Recalling firm
- Westmed Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2011-01-18
- Terminated
- 2012-10-22
- Firm location
- Tucson, AZ, United States
Product description
Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 3 cc, w/Crickett 23g x 1" A Needle, 25U Balanced Heparin, part number: 3383-95, 3344-95, 3353-95. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations.
Reason for recall
Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants.
Data sourced from openFDA. This site is unofficial and independent of the FDA.