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U.S. Department of Health and Human Services

Class 2 Device Recall Pulset Arterial Blood Gas (ABG) sampling kit.

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  Class 2 Device Recall Pulset Arterial Blood Gas (ABG) sampling kit. see related information
Date Initiated by Firm January 18, 2011
Date Posted October 20, 2012
Recall Status1 Terminated 3 on October 22, 2012
Recall Number Z-0097-2013
Recall Event ID 63276
Product Classification Arterial blood sampling kit - Product Code CBT
Product Pulset Arterial Blood Gas (ABG) sampling kit.

Modified Kit, Pulset, 1 cc, with Eclipse, 25 g x 5/8" A Needle, 25U Balanced Heparin, part number: 3165-98.

An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations.
Code Information not available
Recalling Firm/
Manufacturer		 Westmed Inc
5580 S Nogales Hwy Ste 170
Tucson AZ 85706-3333
For Additional Information Contact
520-294-7987 Ext. 1233
Manufacturer 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.
FDA Determined
Cause 2		 Material/Component Contamination
Action 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.
Quantity in Commerce 1,259,200 units total
Distribution Worldwide Distribution-USA (nationwide) and the countries of Canada, El Salvador, United Arab Emirates, Holland, Costa Rica and Lebanon.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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