Recall Z-1277-2015 ยท FPA Set, Administration, Intravascular
US Infusion Inc dba Trucare Biomedix-USA
Medstream 81" (206 cm) 20 drop Universal Administration Sets. Disposable IV infusion set with 3 year expiration date.
| Date | Mar 13, 2015 (initiated Oct 10, 2014) |
| Status | Terminated |
| Reason | Several complaints regarding the IV sets leaking at the Y site. |
| Root cause | Unknown/Undetermined by firm |
| Action | On December 10, 2014 the firm sent an URGENT DRUG RECALL to its consignees. Instructions were to immediately examine inventory and quarantine all product subject to the recall. Customers were asked to complete and return the response form. For returned goods instructions contact Roberta Parness at 866-593-8444 or via email at rparness@tcbiomedix.com. |
| Quantity | 62,700 IV sets |
| Distribution | Distributed in the states of TX, IL, MA, OH, CA, and GA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090012 | DISPOSABLE INFUSION SET Shan Dong Wei Gao Group Medical Polymer Products, Jun 11, 2009 |