Recall Z-0199-06 ยท FPA Set, Administration, Intravascular
Baxter Healthcare Corp.
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
| Date | Nov 26, 2005 (initiated Mar 17, 2005) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 Colle |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K984381 | BURETROL SOLUTION SETS Baxter Healthcare Corp, Feb 19, 1999 |