RAPIDFILL Syringe Strip, For use with RAPIDFILL Automated Syringe Filler (ASF): H93890200 RAPIDFILL Syringe Strip, White

FDA device recall Z-1620-2014 · posted 2014-05-14 · Terminated

Recall details

Recalling firm

Baxter Corporation Englewood

Reason for recall

Possible breach in sterile barrier for inner and outer bags of the product.

Action taken

Baxter sent an Urgent Product Recall letter dated April 30, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Baxter is requesting that you take the following actions: 1. Locate and remove all affected product from your facility (the product code and lot number can be found on the individual product package or shipping carton). 2. To return the affected product, receive credit and order replacement, please contact Baxter Healthcare Center for Service at 1-888-229-0001, Monday through Friday, between the hours of 7:00am and 6:00pm Central Time. Please have your Baxter eight-digit ship-to account number ready when calling. 3. Complete the enclosed customer reply form, and return it to Baxter by either fax or scanned e-mail. 4. If you are a dealer, wholesaler, or distributor/reseller that distributed any product to other facilities, please conduct a recall with your end-user customers in accordance with your customary procedures. If you have questions regarding the content of this communication, please call The Center for One Baxter at 1-800-422-9837 during the hours of 8:00am to 5:00 pm Central Time, Monday through Friday.

Root cause

Process control

Status

Terminated

Product code

FMF

Quantity affected

774, 600

Distribution

Worldwide Distribution - US Distribution including the states of AL, AZ, CT, CA, FL, GA, OH, OR, IL, KS, MA, MI, MN, MO, NC, PA, HI, TN, VA, NV and WI and the country of Canada.

Date initiated

2014-04-16

Date posted

2014-05-14

Date terminated

2015-03-23

Location

Englewood, CO