Baxter Healthcare Corp. Rt. 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Baxter Healthcare Corp. Rt.
Lot Codes / Batch Numbers
all lots of product codes 2C7546(S) and 2C7566(S), as well as A2C7572, A2C9568 and A2C9584 for the Australian market, JC7566 for the Canadian market, and VMC9602P for the European market.
Products Sold
all lots of product codes 2C7546(S) and 2C7566(S), as well as A2C7572, A2C9568 and A2C9584 for the Australian market, JC7566 for the Canadian market, and VMC9602P for the European market.
Baxter Healthcare Corp. Rt. is recalling Buretrol Solution Sets, a sterile fluid pathway of various lengths, 60 drops/mL, with 150 mL Burette due to The Buretrol solution sets are currently labeled as acceptable for use with the Colleague Volumertric Pump, but there is a potential for a non-detect. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026