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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" A Needle, 25U Balanced Heparin, part number: 3372-95. 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-0105-2013

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-0105-2013

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: 38747, 40202, 40423, 40728, 41028, 43127, 44144, 44383, 44648, 44862, 45253, 45825, 46357, 46775, 47079, 47607, 47773, 47733, 48350, 48220, 48809, 48894, 49035, 49095, 49181, 49256, 49326, 49356, 49568, 49717, 49905, 50935.

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.