Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 3 cc, w/Crickett 22g x 1" A Needle, 25U Balanced Heparin, part number: 3342-95. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations.
This recall has been terminated (originally issued October 20, 2012).
- Company
- Westmed Inc
- Recall Initiated
- January 18, 2011
- Posted
- October 20, 2012
- Terminated
- October 22, 2012
- Recall Number
- Z-0100-2013
- Quantity
- 1,259,200 units total
- Firm Location
- Tucson, AZ
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide Distribution-USA (nationwide) and the countries of Canada, El Salvador, United Arab Emirates, Holland, Costa Rica and Lebanon.
Lot / Code Info
Part Number: 3342-95, Lot Numbers: 39212, 38783, 40566, 40636, 40865, 41823, 42380, 43753, 45317, 46270, 46355, 47310, 49450, 49716.
Root Cause
Material/Component Contamination
Action Taken
Westmed sent an "URGENT: MEDICAL DEVICE RECALL" letter dated January 18, 2011 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers were also given the TRIAD GROUP: "Urgent Drug Recall" and "Facts: Alcohol Recall" both dated January 3, 2011. Westmed customers were instructed to remove the TRIAD alcohol pad from the kit and dispose of the alcohol pad only. Customers were instructed to complete and return the enclosed response form as soon as possible. Customers with questions were instructed to contact the firm at (520) 264-7987 x1233.