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Baxter 2B8013 Empty INTRA VIA Container with PVC Ports… recallZ-0085-2015 · Baxter Healthcare Corp · initiated Sep 16, 2014

Class I Terminated All recalls posted in October 2014

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Baxter Healthcare Corp or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Particulate matter found inside the fluid path.

FDA root cause category: Equipment maintenance

What the company is doing

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.

Recall details

Recall number
Z-0085-2015
Recall class
Class I (most serious)
Status
Terminated
Initiated by the company
Sep 16, 2014
Posted by the FDA
Oct 31, 2014
Recalling firm
Baxter Healthcare Corp
Quantity
20448
Product code
KPE
FDA submissions
K964853
Distribution
Nationwide Distribution including Puerto Rico, and the country of Canada.

Product description

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.

Code information (models, lots, serial numbers)

Product code 2B8013 Lot Number: UR13K14095

Other devices under the same FDA submission

7 devices cleared under K964853 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 69181).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page