Device product
Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 3 cc, w/Crickett 23g x 1" A Needle, 25U Balanced Heparin, part number: 3383-95, 3344-95, 3353-95. 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-0109-2013
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-0109-2013
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: 3383-95, Lot Numbers: 43895, 45117, 47953, 48895. Part Number: 3344-95, Lot Numbers: 33814, 39481, 39786, 40083, 40333, 41338, 41642, 41885, 42318, 43129, 43606, 44063, 45116, 45765, 45898, 46358, 46905, 47313, 47595, 48153, 48155, 48154, 48156, 48348, 48624, 49000, 49097, 49100, 49099, 49098, 49102, 49101, 49257, 49841. Part Number: 3353-95, Lot Numbers: 40981, 42106, 45561, 48288, 49258.
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
Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants.