Baxter 2B8011 Empty INTRA VIA Container with PVC Ports, Sterile fluid path, 150 ml, Admixture Products and Accessories.

FDA device recall Z-0084-2015 · posted 2014-10-31 · Terminated

Recall details

Recalling firm

Baxter Healthcare Corp

Reason for recall

Particulate matter found inside the fluid path.

Action taken

Baxter issued a letter to their consignees stating the following: Baxter is requesting that you take the following actions: Action to be taken if product was purchased directly from Baxter. 1. Locate and remove all affected product from all locations in your facility (the product code and lot numbers can be found on the individual product package or shipping carton). 2. Contact Baxter Healthcare Center for Service to arrange for return and credit. The Center for Service can be reached at 888-229-0001 between the hours of 7:00 am and 6:00 pm 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 tax or scanned e-mail. 4. If you distributed any of the affected products to other facilities, please conduct a recall with your end-user customers in accordance with your customary procedures. Baxter distributed product 2B8011 lot U R 13D 15112 to customers between 4/26/2013 and 6/20/2013. Baxter distributed product 2B8013 lot UR13K1 4095 to customers between 11 /27/2013 and 3/ 10/2014. Action to be taken if product was received from an alternate source. 1. Locate and remove all of the affected products from all locations in your facility (the product code and lot numbers can be found on the individual product package or shipping carton). 2. Contact Baxter Healthcare Center for Service to arrange for return and credit. The Center for Service can be reached at 888-229- 0001 between the hours of 7:00 am and 6:00 pm Central Time. Please have your ship-to account number ready when calling. 3. Follow your supplier's reply and recall process. Please do not return the customer reply form to Baxter.

Root cause

Equipment maintenance

Status

Terminated

Product code

KPE

Quantity affected

94,224

Distribution

Nationwide Distribution including Puerto Rico, and the country of Canada.

Date initiated

2014-09-16

Date posted

2014-10-31

Date terminated

2017-06-21

Location

Deerfield, IL

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