Recall Z-2070-2014 ยท LHI Set, I.V. Fluid Transfer
Excelsior Medical Corp
Excelsior Medical Sterile Triple Lead Tubing Set and Sterile Heavy Duty Triple Lead Tubing Set. To be used with the Pharm-Assist Dispensing Pump. Used for drug reconstitution and/or fluid transfer
| Date | Jul 16, 2014 (initiated Jun 5, 2014) |
| Status | Terminated |
| Reason | There is a potential for a leak. A molding defect in the connector that joins the three leads to the main flow line may allow fluid to escape or air to enter the fluid path during transfer of fluids from one container to another. |
| Root cause | Nonconforming Material/Component |
| Action | Excelsior Medical issued "Urgent Medical Device Recall" notifications/"Customer Reply Forms" dated June 5, 2014 to affected customers via certified mail (return receipt request). The notice informed customers of the issue with the affected product; how to identify affected product; instructed the customers to discontinue use of tubing sets from the affected lots and return the attached form (Customer Reply Form) via fax to Excelsior to make arrangements for return of product. If product was further distributed by the customer the notification instructs them to identify the customer(s) that i |
| Quantity | 4250 tubing sets (PA03 - 78 cases; BX03 - 92 cases (each case contains 25 tubing sets)) |
| Distribution | Worldwide Distribution - USA (nationwide) and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K913804 | EXCELSIOR SINGLE LEAD DISPENSING SET Excel Medical, Inc., Feb 11, 1992 |