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Baxter CLEARLINK System Non-DEHP Three Lead Extension Set.… recallZ-0099-2014 · Baxter Healthcare Corp. · initiated Sep 4, 2013

Class II Terminated All recalls posted in October 2013

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

The firm is issuing a voluntary recall due to the potential for pinholes in the packaging. Pinholes are a breach in the sterile barrier and could lead to potential contamination.

FDA root cause category: Under Investigation by firm

What the company is doing

Baxter sent an Urgent Product Recall letter dated September 9, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions to be taken by Customer/User: 1. Locate and remove all affected product from your facility. If you distribute these products to other facilities or departments within your institution, please forward a copy of this communication to ensure that they locate and remove affected product from potential use. The product code and lot number can be found on the shipping carton label and individual product package. 2. Acknowledge your receipt of this recall notification by completing the attached Customer Reply Form (Attachment 1) and return it to Baxter by either faxing it to 224-270-5457 or scanning and emailing it to [email protected]. Returning the Customer Reply Form promptly will prevent you from receiving repeat notifications. 3. The affected product should be returned for credit by contacting Baxter Healthcare Center for Service. 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.Please have the product code and lot number(s) available.

Recall details

Recall number
Z-0099-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Sep 4, 2013
Posted by the FDA
Oct 29, 2013
Recalling firm
Baxter Healthcare Corp.
Quantity
3,200 units
Product code
FPA
FDA submissions
K112893
Distribution
US Distribution including the states of OK, GA, CA, MN, TX and HI.

Product description

Baxter CLEARLINK System Non-DEHP Three Lead Extension Set. 6.0" (15 cm), 1.0 mL, Luer Activated Valve, male Luer Lock Adapter, Sterile, nonpyrogenic, Baxter Healthcare Corporation, Deerfield IL 60015. For use with a vascular access device for the administration of drugs and solutions. The Clearlink Luer Activated Valve is an in-line injection site, which can be connected to standard male Luer adapters for continuous or intermittent fluid administration or the withdrawal of fluids.

Code information (models, lots, serial numbers)

UR13C11089, UR13D16060

Other devices under the same FDA submission

21 devices cleared under K112893 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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