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Baxter***Non-DEHP***BURETROL Solution Set recallZ-2615-2014 · Baxter Healthcare Corp · initiated Jul 14, 2014

Class II Terminated All recalls posted in September 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

Baxter Healthcare Corporation is voluntarily issuing a recall for specific lots of Buretrol Solution set product codes due to complaints for separation between the burette chamber and the drip chamber. Affected product codes are: 2C7564, 2C8864 and 2H8864.

FDA root cause category: Nonconforming Material/Component

What the company is doing

Action to be taken if product was purchased directly from Baxter: 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. 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 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. Baxter distributed this product to customers between September 27, 2013, and April 25, 2014. Action to be taken if the products were purshased from a distributor or re-seller. 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. 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-2615-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Jul 14, 2014
Posted by the FDA
Sep 9, 2014
Recalling firm
Baxter Healthcare Corp
Quantity
11184
Product code
FPA
FDA submissions
K123874
Distribution
Nationwide Distribution.

Product description

***Baxter***Non-DEHP***BURETROL Solution Set 105" (2.7 m), 150 mL Burette***Drip Chamber Filter Valve 3 Luer Activated Valves***Male Luer Lock Adapter***with Retractable Collar***Fluid path is Sterile, Nonpyrogenic.***Indications for Use: For the administration of fluids from a container into the patient's vascular system through a vascular access device.***

Code information (models, lots, serial numbers)

2H8864- Non-DEHP Buretrol Solution Set, 150 mL CLEARLINK Burette, lots: DR13E10011 DR13E10029 DR13E11019 DR14A13013 DR14C08043

Other devices under the same FDA submission

9 devices cleared under K123874 — 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 68843).

Sources and updates

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