Recall Z-1730-2015 ยท FPA Set, Administration, Intravascular
Smiths Medical Asd Inc
Low Volume Extension Set, 72' w/Clamp FLL/MLL APV=1.3ml, STERILE, AND FLUID PATH NONPYROGENIC UNLESS PACKAGE IS DAMAGED OR OPENED. LATEX FREE, SINGLE USE Tyvek pouches, 10 per box, Smiths Medical ASD, Inc. Used to administer fluid and drugs intravenously.
| Date | Jun 8, 2015 (initiated May 4, 2015) |
| Status | Terminated |
| Reason | Smiths Medical has become aware of an issue with the Low Volume Extension Set, (72'' Extension Set) where under-sized tubing was used in the production of 1 lot of product. |
| Root cause | Process control |
| Action | Smiths Medical sent Urgent Medical Device Recall Notice letters, dated 4 May 2015, requiring its customers to return all affected unused Extension Sets. Please take the following actions: 1. Customers are to inspect their inventory and quarantine any affected Extension Sets. 2. Complete and return the attached Confirmation Form by Fax or by e-mail 3. Upon receipt of the completed form, a customer service representative will contact customers to arrange for exchange of their unused affected Extension Sets for credit or replacement. The notice shall be passed on to all personnel who need to |
| Quantity | 6,000 units |
| Distribution | Distributed to the states of KY, MN, NJ, UT, & WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K831087 | MINI-VOL EXTENSION SET Beech Medical, Inc., Apr 28, 1983 |