Recall Z-0103-2013 ยท CBT Arterial Blood Sampling Kit
Westmed Inc
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.
| Date | Oct 20, 2012 (initiated Jan 18, 2011) |
| Status | Terminated |
| 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. |
| Root cause | Material/Component Contamination |
| Action | Westmed sent an "URGENT: MEDICAL DEVICE RECALL" letter dated January 18, 2011 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers were also given the TRIAD GROUP: "Urgent Drug Recall" and "Facts: Alcohol Recall" both dated January 3, 2011. Westmed customers were instructed to remove the TRIAD alcohol pad from the kit and dispose of the alcohol pad only. Customers were instructed to complete and return the enclosed response form as soon as possible. Customers with questions were instructed to contact the firm at (520 |
| Quantity | 1,259,200 units total |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of Canada, El Salvador, United Arab Emirates, Holland, Costa Rica and Lebanon. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.