ISSUE: Baxter International Inc. announced it has
initiated a voluntary recall of two lots of its Dual Luer Lock Caps (Product
Code 2C6250, Lots 10043 and 10044) because of the presence of loose particulate
matter found in the packaging. Particulate matter entering the fluid path from
the Luer Lock Caps may result in thrombotic and embolic events, including: pulmonary
embolism, myocardial infarction and stroke. There have been no reported
complaints associated with thisissue, however embolic events may not be
easily attributed to such particulate matter. The root cause has been
identified and resolved. FDA has designated this as a Class I recall.
BACKGROUND: Baxter's Dual Luer Lock Cap is used as a
protective cap on access ports on medical devices such as stopcocks or IV sets
when not in use. Affected lots were distributed to customers between June 19,
2013, and August 20, 2013.
RECOMMENDATION: Customers should not use product from the
two recalled lots and should locate and remove all affected product from their
facility. Non-affected lot numbers can continue to be used according to the
instructions for use.Affected lots should be returned to Baxter for
credit by contacting Baxter Healthcare Center for Service at 1-888-229-0001
between the hours of 7:00 a.m. and 6:00 p.m., Central Time.
Healthcare professionals and patients are
encouraged to report adverse events or side effects related to the use of these
products to the FDA's MedWatch Safety Information and Adverse Event Reporting
and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to
request a reporting form, then complete and return to the address on the
pre-addressed form, or submit by fax to 1-800-FDA-0178
MedWatch Safety Alert, including links to the Firm Press Release HERE.
Source: U.S. Food and Drug
Administration (FDA) (Accessed: 9/20/2013)