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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 23g x 1" A Needle, Luer Slip Barrel, 25U Balanced Heparin, No B Needle or Q-Cork, part number: 3363-95S. 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-0103-2013

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-0103-2013

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: 43406, 43607, 44030, 44062, 44264, 44327, 44422, 44863, 44981, 45262, 46124, 46886, 46585, 47077, 47312, 48831.

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.