Recall Z-0653-06 ยท FMG Stopcock, I.V. Set
Baxter Healthcare Corp.
Baxter Interlink System Continu-Flo Solution Set with Standard Bore 4-Way Stopcock Manifold Extension Set and Minivolume Extension Set, product code 3C0078; An Rx sterile, nonpyrogenic fluid pathway; solution set: 74'', 60 drops/mL, with injection site and male Luer Lock adapter, manifold extension set: 29'', 4 mL Vol, male luer adapter, and minivolume extension set: 7'', 0.4 mL Vol with retractab
| Date | Mar 24, 2006 (initiated Dec 15, 2005) |
| Status | Terminated |
| Reason | The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication. |
| Root cause | Other |
| Action | Baxter sent Urgent Product Recall letters dated 8/3/05 to their customers, to the attention of the Director of Materials Management, via first class mail on the same date. The accounts were informed of the microbore female luers that may crack during use, resulting in the possible under delivery or incomplete delivery of medication. The accounts were instructed to examine their inventory for the affected lots of product, remove it from inventory and return it to Baxter for credit. Any questions were directed to the Center for One Baxter at 1-800-422-9837. Baxter extended the recall to include |
| Quantity | 1,920 sets |
| Distribution | Nationwide, including Puerto Rico and American Samoa, and internationally to Canada, Australia, Japan, South Korea, Saudi Arabia, India, Mexico, Venezuela, Malaysia, East Timor and New Zealand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022895 | ELCAM STOPCOCKS AND MANIFOLDS Medical Device Consultants, Inc., Oct 18, 2002 |
| K921899 | INTERLINK SYSTEM - T-CONNECTOR EXTENSION SET Baxter Healthcare Corp, Apr 20, 1993 |
| K961225 | CONTINUFLO SOLUTION SET/SECONDARY MEDICATION SET Baxter Healthcare Corp, Jun 21, 1996 |
| K962581 | STOPCOCK MANIFOLD GANGS Baxter Healthcare Corp, Aug 28, 1996 |