—#86463

Product

Buretrol Solution Sets, a sterile fluid pathway of 105 (2.7 m), 60 drops/mL, with 150 mL Burette Drip Chamber Filter Valve, 2 injection Y-sites, 3 Luer Activated Valves and Male Luer Lock Adapter with Retractable Collar; 48 individually pouched sterile sets per case; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A. A sterile fluid pathway used to administer fluids from a container to a patient's vascular system through a vascular access device.

FDA product code: FPA — Set, Administration, Intravascular
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K984381
Affected lot / code info: Product code 2C8864; Lot number UR09E21238.

Why it was recalled

The tubing may separate from the distal Clearlink Y-site of the set, which could result in patient injury if the separation occurs during patient use.

Root cause (FDA determination)

Employee error

Action the firm took

An "Urgent Product Recall" letter dated November 3, 2009 was sent to the direct accounts via first class mail on the same date, to the attention of the Director of Nursing and the Director of Materials Management. The letter informed the accounts that there have been reports of a separation of the tubing from the distal Clearlink Y-site of the set, with one instance resulting in a serious injury. The accounts were instructed to examine their inventory and remove any sets of Product code 2C8864, Lot number UR09E21238 from inventory and return the affected product for credit or replacement product by calling Baxter Healthcare Center for Service at 1-888-229-0001, Prompt 2, during hours of operation 7:00 a.m. to 6:00 p.m. Central Standard Time. Questions regarding the communication were directed to the Center for One Baxter at 1-800-422-9837 during the hours of 8:00 a.m. to 5:00 p.m. Central Standard Time. If the accounts further distributed the Buretrol Sets, they were requested to forward the communication to those accounts. The accounts were also requested to complete and fax back to Baxter the enclosed reply sheet confirming receipt of the letter.

Recalling firm

Firm: Baxter Healthcare Corp. Rt.
Address: 120 & Wilson Rd, Round Lake, Illinois 60073

Distribution

Distribution pattern: Worldwide Distribution -- United States (Alabama, California, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Michigan, Mississippi, Missouri, Nevada, New Mexico, Ohio, Tennessee, Texas, Utah and Wisconsin), Canada and New Zealand.

Timeline

Recall initiated: 2009-11-03
Posted by FDA: 2009-12-09
Terminated: 2010-07-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #86463. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.