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Recall Observatory FDA recall evidence

Device product

Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 3 cc, w/Crickett 23g x 1" A Needle, 25U Balanced Heparin, part number: 3373-95. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations.

Z-0107-2013

January 18, 2011

Class II

Product summary

Firm
Westmed Inc
Event
Event 63276
Status
Terminated
Classification
Class II
Quantity
1,259,200 units total
Official record key
device-enforcement:Z-0107-2013

Official wording

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.

Code information: Lot Numbers: 38784, 39142, 39144, 39145, 39211, 39137, 39141, 39322, 39321, 39629, 39628, 39630, 39830, 39831, 39832, 40424, 40625, 40950, 41402, 41415, 42070, 42416, 42517, 42858, 43325, 43196, 43577, 43982, 44146, 44678, 45562, 45671, 45826, 46340, 46470, 46780, 46779, 47081, 47174, 47370,47487, 47597, 47606, 47847, 48484, 48580, 48625, 48811, 48860, 48896, 49036, 49260, 49357, 49473, 49569, 49906.

Distribution pattern: Worldwide Distribution-USA (nationwide) and the countries of Canada, El Salvador, United Arab Emirates, Holland, Costa Rica and Lebanon.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants.