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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 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.

Z-0102-2013

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-0102-2013

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: 39560, 39833, 40185, 40201, 40332, 40983, 41027, 41253, 41693, 41884, 42224, 42592, 42977, 43290, 43373, 43564, 43670, 43752, 44143, 44333, 44677, 44752, 45212, 45559, 45560, 45699, 46107, 46356, 46271, 46654, 46923, 47078, 47218, 47774, 48288, 48143.

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.