Baxter Interlink System Buretrol Solution Set, 83" (2.1 m), 150 mL Burette Drip Chamber Filter Valve, 2 Injection Sites,

FDA device recall Z-0070-2011 · posted 2010-10-15 · Terminated

Recall details

Recalling firm

Baxter Healthcare Corp.

Reason for recall

There are leaks in the Drip Chamber Check Valve Subassembly of the Solution Set. A leak in a sterile pathway could allow microbial entry, which could lead to a blood stream infection.

Action taken

Baxter sent an "Urgent Product Recall" letter dated September 2, 2010, via first class mail to the direct account, to the attention of the Director of Materials Management, with a copy sent to the Director of Nursing, on the same date, informing them that leaks were detected in the Drip Chamber Check Valve Subassembly used in the affected lot of Interlink System Buretrol Solution Sets. A leak in a sterile pathway could allow microbial entry, which could lead to a blood stream infection. The account was requested to examine their inventory in all locations to determine if they have any of the affected lot and remove the affected product from inventory; call Baxter Healthcare Center for Service at 1-888-229-0001 to return the affected product, request a credit, or request replacement product; complete the attached customer reply form confirming their receipt of the letter and fax it to Baxter at the number provided on the form. Dealers, wholesalers and distributors were requested to notify their customers of this action so they can comply with the procedures listed above. Any questions regarding the communication were directed to The Center for One Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm CST.

Root cause

Employee error

Status

Terminated

Product code

FPA

Quantity affected

948 units

Distribution

Nationwide distribution: Wisconsin only.

Date initiated

2010-09-03

Date posted

2010-10-15

Date terminated

2011-02-25

Location

Round Lake, IL

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