Z-0101-2013 Class II Terminated
FDA device recall Z-0101-2013 was initiated by Westmed Inc on January 18, 2011 and is designated Class II. 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. The recall status is terminated (terminated October 22, 2012). Affected quantity: 1,259,200 units total.
Recall Details
- Product Type
- Devices
- Report Date
- October 31, 2012
- Initiation Date
- January 18, 2011
- Termination Date
- October 22, 2012
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,259,200 units total
Product Description
Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 3 cc, w/Crickett 23g x 1" A Needle, 25U Balanced Heparin, No B Needle or Q-Cork, part number: 3363-95. 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.
Distribution Pattern
Worldwide Distribution-USA (nationwide) and the countries of Canada, El Salvador, United Arab Emirates, Holland, Costa Rica and Lebanon.
Code Information
Lot Numbers: 38637, 38915, 39143, 39147, 39146, 39392, 39745, 39746, 39747, 39748, 40014, 40226, 40225, 40224, 40223, 40565, 40910, 40567, 40955, 41086, 41087, 41317, 41413, 41412, 41414, 41592, 41973, 42071, 42171, 42321, 42595, 42319, 43180, 43130, 43405,43618, 43751, 44064, 44104, 44145, 44384, 44566, 44835, 45057, 45058, 45257, 45255, 45256, 45366, 45669, 45766, 45882, 46108, 46108, 46122, 46339, 46469, 46777, 46655, 46974, 47080, 47226, 47314, 47434, 47596, 47651, 47747, 47746, 48157, 48221, 48483, 48579, 48507, 48623, 48622, 48482, 48762, 48810, 48971, 48927, 49096, 49182, 49259, 49301, 49304, 49303, 49305, 49451, 49586, 49786, 49842.