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Recall Observatory FDA recall evidence

Device product

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.

Z-0100-2013

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-0100-2013

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: Part Number: 3342-95, Lot Numbers: 39212, 38783, 40566, 40636, 40865, 41823, 42380, 43753, 45317, 46270, 46355, 47310, 49450, 49716.

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.