Baxter 2B8013 Empty INTRA VIA Container with PVC Ports (Sterile, nonpyrogenic fluid path) ,500 ml. Admixture Products and Accessories The lntraVia Empty Plastic Container is intended for use in the preparation and administration of drug admixtures.
FDA Recall Z-0085-2015 · Posted 2014-10-31
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Recalling FirmBaxter Healthcare Corp
Recall StatusTerminated
Product CodeKPE
Date Initiated2014-09-16
Date Terminated2017-06-21
Product Quantity20448
Reason for Recall
Particulate matter found inside the fluid path.
Firm Action
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
Distribution Pattern
Nationwide Distribution including Puerto Rico, and the country of Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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