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Baxter Interlink System Buretrol Solution Set with Large… recallZ-0656-06 · Baxter Healthcare Corp. · initiated Dec 15, 2005

Terminated All recalls posted in March 2006

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 extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.

FDA root cause category: Other

What the company is doing

Baxter sent Urgent Product Recall letters dated 8/3/05 to their customers, to the attention of the Director of Materials Management, via first class mail on the same date. The accounts were informed of the microbore female luers that may crack during use, resulting in the possible under delivery or incomplete delivery of medication. The accounts were instructed to examine their inventory for the affected lots of product, remove it from inventory and return it to Baxter for credit. Any questions were directed to the Center for One Baxter at 1-800-422-9837. Baxter extended the recall to include additional lots and product codes via letter dated 12/15/05. The letters referenced the 8/3/05 letter, including a copy of that letter, and listed the affected lots of sets. The instructions for return of the product remained the same as that described in the 8/3/05 letter.

Recall details

Recall number
Z-0656-06
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Dec 15, 2005
Posted by the FDA
Mar 24, 2006
Recalling firm
Baxter Healthcare Corp.
Quantity
870 sets
Product code
FMG
FDA submissions
K022895, K921899, K962581, K984381
Distribution
Nationwide, including Puerto Rico and American Samoa, and internationally to Canada, Australia, Japan, South Korea, Saudi Arabia, India, Mexico, Venezuela, Malaysia, East Timor and New Zealand.

Product description

Baxter Interlink System Buretrol Solution Set with Large Bore 4-Way Stopcock with Rotating Male Luer Lock Extension Set and Extension Set, product code 3C0172; An Rx sterile, nonpyrogenic fluid pathway; solution set: 84'', 60 drops/mL, with 150 mL Burette Drip Chamber Filter Valve, 3 injection sites and male Luer Lock adapter, stopcock extension set: 21'', 3.2 mL Vol with 2 injection sites and male luer adapter, and minivolume extension set: 6'', 0.5 mL Vol with microvolume tubing and retractable T-connector; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.

Code information (models, lots, serial numbers)

product code 3C0172, lot GR230631

Other devices under the same FDA submission

4 devices cleared under K022895, K921899, K962581, K984381 — 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 34290).

Sources and updates

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