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Terminated

Buretrol Solution Sets, a sterile fluid pathway of various lengths, 60 drops/mL, with 150 mL Burette Ball Valve, 2 injection sites and male luer lock adapter; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A

FDA Recall Z-0199-06 · Posted 2005-11-26

Recalling FirmBaxter Healthcare Corp.
Recall StatusTerminated
Product CodeFPA
Date Initiated2005-03-17
Date Terminated2008-03-04
Product Quantity7,507,494 sets

Reason for Recall

The Buretrol solution sets are currently labeled as acceptable for use with the Colleague Volumertric Pump, but there is a potential for a non-detection of an upstream occlusion under certain conditions.

Firm Action

Urgent Device Correction letters dated 3/17/05 were sent to the direct accounts via first class mail on 3/17/05, to the attention of the director of nursing. The letters informed the accounts that there is a potential for a non-detection of an upstream occlusion under certain conditions if the product codes 2C7546(S) and 2C7566(S) Buretrol Solution Sets are used with the Colleague Infusion Pumps. Baxter recommends that these product codes no longer be used with the Colleague pumps, and listed product codes 2C7519(S) and 2C7564(S) as alternative compatible sets that can be used with the Colleague pumps. Any questions concerning the compatibility of other Buretrol sets with the Colleague pumps were directed to Baxter Medication Delivery Product Information Center at 1-800-933-0303. Since teh two product codes are no longer recommended for COlleague pumps, the accounts were given the choice of returning their stocks of the two product codes for credit and order an alternative by calling Baxter Healthcare Center for Service at 1-888-229-0001. Questions regarding the communication were directed to the Center for One Baxter at 1-800-422-9837.

Root Cause

Other

Distribution Pattern

Nationwide, including Puerto Rico and American Samoa, and internationally to Japan, Mexico, Australia, New Zealand, Hong Kong, Singapore, Switzerland, China, Uruguay, East Timor, Armenia and Panama.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K984381BURETROL SOLUTION SETSBaxter Healthcare Corp · 1999-02-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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