Vented Spike Adapter Product Code 2C0471, Sterile, nopyrogenic. Manufactured by an affiliate of Baxter Healthcare Corpor

FDA device recall Z-0109-2014 · posted 2013-10-30 · Terminated

Recall details

Recalling firm

Baxter Healthcare Corp.

Reason for recall

Potential tears in the pouch of six lots of Vented Spike Adapter Product Code 2C0471

Action taken

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 fca@baxter.com; 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

Status

Terminated

Product code

FPA

Quantity affected

49,344 units

Distribution

Nationwide distribution.

Date initiated

2013-08-30

Date posted

2013-10-30

Date terminated

2017-04-19

Location

Deerfield, IL