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U.S. Department of Health and Human Services

Class 1 Device Recall Baxter 2B8011 Empty INTRA VIA Container with PVC Ports

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  Class 1 Device Recall Baxter 2B8011 Empty INTRA VIA Container with PVC Ports see related information
Date Initiated by Firm September 16, 2014
Date Posted October 31, 2014
Recall Status1 Terminated 3 on June 21, 2017
Recall Number Z-0084-2015
Recall Event ID 69181
510(K)Number K964853  
Product Classification Container, i.V. - Product Code KPE
Product Baxter 2B8011 Empty INTRA VIA Container with PVC Ports, Sterile fluid path, 150 ml, Admixture Products and Accessories.

The lntraVia Empty Plastic Container is intended for use in the preparation and administration of drug admixtures.
Code Information Product code: 2B8011 Lot Number: UR13D15112 
Recalling Firm/
Manufacturer		 Baxter Healthcare Corp
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information Contact Center for One Baxter
847-948-4770
Manufacturer Reason
for Recall		 Particulate matter found inside the fluid path.
FDA Determined
Cause 2		 Equipment maintenance
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.
Quantity in Commerce 94,224
Distribution Nationwide Distribution including Puerto Rico, and the country of Canada.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KPE and Original Applicant = BAXTER HEALTHCARE CORP.
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