Z-0103-2013Class II

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

Name: Z-0103-2013 Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 3 cc, w/Crickett 23g x 1" A Needle, Luer...
Creator: Westmed Inc
Published: 2011-01-18
License: https://open.fda.gov/license/

Westmed Inc / initiated 2011-01-18 / Terminated / root cause: manufacturing process

FDA source

Westmed Inc began a recall of 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... on 2011-01-18. FDA classified it as Class II and gives the reason as "Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0103-2013
Classification: Class II
Status: Terminated
Initiated: 2011-01-18
Posted: 2012-10-20
Terminated: 2012-10-22
Recalling firm: Westmed Inc
Product: 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.
Product code: CBT Arterial Blood Sampling Kit
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.
Root cause tag: manufacturing process
FDA 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) 264-7987 x1233.
Quantity in commerce: 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.
Product codes and lots: Lot Numbers: 43406, 43607, 44030, 44062, 44264, 44327, 44422, 44863, 44981, 45262, 46124, 46886, 46585, 47077, 47312, 48831.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0103-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0096-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-31	2012-10-20
Z-0097-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-31	2012-10-20
Z-0098-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-31	2012-10-20
Z-0099-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-31	2012-10-20
Z-0100-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-31	2012-10-20
Z-0101-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-31	2012-10-20
Z-0102-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-31	2012-10-20
Z-0103-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-31	2012-10-20
Z-0104-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-31	2012-10-20
Z-0105-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-31	2012-10-20
Z-0106-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-31	2012-10-20
Z-0107-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-31	2012-10-20
Z-0108-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-31	2012-10-20
Z-0109-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-31	2012-10-20

Product code CBT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)