Buretrol Solution Sets, a sterile fluid pathway of 105 (2.7 m), 60 drops/mL, with 150 mL Burette Drip Chamber Filter Val

FDA device recall Z-0487-2010 · posted 2009-12-09 · Terminated

Recall details

Recalling firm

Baxter Healthcare Corp.

Reason for recall

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.

Action taken

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.

Root cause

Employee error

Status

Terminated

Product code

FPA

Quantity affected

173 cases

Distribution

Worldwide Distribution -- United States (Alabama, California, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Michigan, Mississippi, Missouri, Nevada, New Mexico, Ohio, Tennessee, Texas, Ut

Date initiated

2009-11-03

Date posted

2009-12-09

Date terminated

2010-07-08

Location

Round Lake, IL

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