Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 3 cc, w/Crickett 23g x 1" A Needle, 25U Balanced Hep

FDA device recall Z-0109-2013 · posted 2012-10-20 · Terminated

Recall details

Recalling firm

Westmed Inc

Reason for recall

Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants.

Action taken

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) 264-7987 x1233.

Root cause

Material/Component Contamination

Status

Terminated

Product code

CBT

Quantity affected

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.

Date initiated

2011-01-18

Date posted

2012-10-20

Date terminated

2012-10-22

Location

Tucson, AZ