Recall Z-0837-03 ยท FPA Set, Administration, Intravascular
Specialized Health Products, Inc.
SHPI LIftLoc Safety Infusion Sets
| Date | May 15, 2003 (initiated Apr 17, 2003) |
| Status | Terminated |
| Reason | Pouch seals on Safety Infusion Sets may be defective, possibly compromising sterility. |
| Root cause | Other |
| Action | The single consignee (BAS) was notified by lettter on 4/14/03. |
| Quantity | 2240 units |
| Distribution | Utah. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013394 | LIFTLOC SAFETY INFUSION SET Specialized Health Products, Inc., Nov 8, 2001 |