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Class 2 Device Recall Baxter and Baxter Interlink Buretrol Solution Sets |
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Date Initiated by Firm |
March 17, 2005 |
Date Posted |
November 26, 2005 |
Recall Status1 |
Terminated 3 on March 04, 2008 |
Recall Number |
Z-0199-06 |
Recall Event ID |
31469 |
510(K)Number |
K984381
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Product Classification |
Set, Administration, Intravascular - Product Code FPA
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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 |
Code Information |
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. |
Recalling Firm/ Manufacturer |
Baxter Healthcare Corp. Rt. 120 & Wilson Rd Round Lake IL 60073
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For Additional Information Contact |
Center for One Baxter 800-422-9837
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Manufacturer 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.
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FDA Determined Cause 2 |
Other |
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. |
Quantity in Commerce |
7,507,494 sets |
Distribution |
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. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = FPA and Original Applicant = BAXTER HEALTHCARE CORP.
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