Device product
Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 3 cc, 23g x 1" A/B Needle, 25U Balanced Heparin, part numbers: 3373, 3393. 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-0106-2013
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-0106-2013
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 3373, Lot Numbers: 38813, 38634, 39148, 39946, 40951, 40952, 41593, 41740, 42914, 43291, 43999, 45252, 46341, 46653, 47175, 47371, 48029, 48266, 48351, 48495, 48661, 48897, 49145, 49236, 49325, 49408, 49522, 49718, 49966. Part Number: 3393, Lot numbers: 38995, 33994, 39788, 40082, 40568, 40569, 40674, 40994, 41325, 41326, 41749, 41931, 44536, 44534, 44535, 44533.
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.