Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 3 cc, w/Crickett 22g x 1", 25U Balanced Heparin, part number: 3362-95. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations.
FDA Recall Z-0102-2013 · Posted 2012-10-20
Advertisement
Recalling FirmWestmed Inc
Recall StatusTerminated
Product CodeCBT
Date Initiated2011-01-18
Date Terminated2012-10-22
Product Quantity1,259,200 units total
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.
Firm 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.
Root Cause
Material/Component Contamination
Distribution Pattern
Worldwide Distribution-USA (nationwide) and the countries of Canada, El Salvador, United Arab Emirates, Holland, Costa Rica and Lebanon.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement