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Baxter Interlink System Extension Set, 13" (32 cm), Check… recallZ-0475-2012 · Baxter Healthcare Corp. · initiated Dec 6, 2011

Terminated All recalls posted in January 2012

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

During production of the IV sets, solvent was inadvertently applied to the locking collar of the male luer connector, which may have damaged the component, preventing proper engagement of the locking collar to secure a connection.

FDA root cause category: Employee error

What the company is doing

The firm, Baxter, sent an "Urgent Product Recall" letter dated December 6, 2011, via first class mail to its customers. The letter described the product, problem, and actions to be taken. The customers were instructed to inspect all locations where their facility's inventory is located for products with the affected lot numbers; return the affected product; request a credit or replacement by calling Baxter Healthcare Center for Service at 1-888-229-0001 between 7:00am to 6:00pm Central time, Monday through Friday; complete and return the attached Customer Reply Form via fax to: 1-847-270-5457, or scan and email to [email protected]; and if they are a dealer, wholesaler, or distributor/reseller that distributed any affected product to other facilities, please notify their customers of this recall. If you have any questions regarding the communication, please call The Center for One Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm CST.

Recall details

Recall number
Z-0475-2012
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Dec 6, 2011
Posted by the FDA
Jan 11, 2012
Recalling firm
Baxter Healthcare Corp.
Quantity
4,560 units
Product code
FPA
FDA submissions
K961225
Distribution
Worldwide distribution: USA (nationwide) including states of: Alaska, California, Colorado, Florida, Georgia, Hawaii, Illinois, Kansas, Kentucky, Massachusetts, Maine, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Virginia, Washington, Wisconsin and West Virginia; and country of: New Zealand.

Product description

Baxter Interlink System Extension Set, 13" (32 cm), Check Valve, Injection Site, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the patient; Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 2C6605 Intended use: for the administration of drug and solutions to patient's vascular system through a vascular access device

Code information (models, lots, serial numbers)

product code 2C6605, lot number GR295725

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.

Other products in the same recall event

The FDA groups related products into one recall event (event 60608).

Sources and updates

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