Vented Spike Adapter Product Code 2C0471, Sterile, nopyrogenic. Manufactured by an affiliate of Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield IL 60015 USA. An IV transfer device, used to transfer fluids in pharmacy compounding system.
FDA Recall Z-0109-2014 · Posted 2013-10-30
Recalling FirmBaxter Healthcare Corp.
Recall StatusTerminated
Product CodeFPA
Date Initiated2013-08-30
Date Terminated2017-04-19
Product Quantity49,344 units
Reason for Recall
Potential tears in the pouch of six lots of Vented Spike Adapter Product Code 2C0471
Firm Action
The firm, Baxter, sent an "Urgent Product Recall" letter dated September 10, 2013 to its consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to locate and remove all affected product from your facility; If you distributed the products to other facilities or departments, forward them a copy of the letter; complete and return the attached Customer Reply Form via fax to 1-224-270-5457 or scan and email to [email protected]; and contact Baxter Healthcare Center for Service at 1-888-229-0001 between hours of 7:00 am and 6:00pm Central Time to return affected product and receiving credit.
For additional information contact the Center for One Baxter at 1-800-422-9837, Monday thru Friday during the hours of 8:00am to 5:00pm Central Time.
Root Cause
Packaging
Distribution Pattern
Nationwide distribution.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.