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Baxter Solution Set with Duo-Vent Spike recallZ-2920-2011 · Baxter Healthcare Corp. · initiated Jul 21, 2011

Terminated All recalls posted in August 2011

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 Solution Sets are being recalled because the position of the slide clamp and roller clamp may have been reversed during assembly. The reversed orientation of the slide clamp and roller clamp will cause the set to be incorrectly loaded into an infusion pump, resulting in fluid flow from the patient to the pump, rather than from the pump to the patient.

FDA root cause category: Employee error

What the company is doing

Baxter Healthcare Corporation sent a "Urgent Product Recall" letter dated July 21, 2011 to all affected customers. The letter included a description of the problem and requested they contact Baxter at 1-888-229-0001 to return all affected product. They were asked to complete and return the attached customer reply form, and to contact and notify their customers. For questions contact Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm CST.

Recall details

Recall number
Z-2920-2011
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jul 21, 2011
Posted by the FDA
Aug 3, 2011
Recalling firm
Baxter Healthcare Corp.
Quantity
4,752 units
Product code
FPA
FDA submissions
K961225
Distribution
(USA) Nationwide Distribution including the states of Alabama, California, Iowa, Illinois, Indiana, Massachusetts, Maryland, Michigan, North Carolina, New Hampshire, Ohio, Pennsylvania, Tennessee and Virginia.

Product description

Baxter Solution Set with Duo-Vent Spike; 109" (2.8 m), Male Luer Lock Adapter 10 drops/mL. Baxter Healthcare Corporation. A sterile, single use, nonpyrogenic fluid pathway for use with rigid nonvented and flexible containers.

Code information (models, lots, serial numbers)

Product Code 1C8507s, lot numbers GR291542, GR292409, GR292797 and GR294454.

Other devices under the same FDA submission

24 devices cleared under K961225 — 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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