Recall Z-0497-2018 ยท MEA Pump, Infusion, Pca
Smiths Medical ASD Inc.
Graseby 3300 Pump and Graseby 3000 Series Pump Accessories Patient controlled syringe pump. Use for Infusion
| Date | Aug 24, 2017 |
| Status | Terminated |
| Reason | In certain cases, the lock and key supplied with Graseby 3300 pumps and accessories does not match the standard Graseby 3300 key. |
| Root cause | Nonconforming Material/Component |
| Action | Notification was sent to customers on August 24, 2017. Included with the Product Safety & Recall Notification, Instructions to Customers and the Recall response Form. Customers who find product subject to the recall are to contact Smith Medical Customer Service Department to make arrangements to have the affected products returned to Smiths. For further questions, please call (763) 383-3072. |
| Quantity | 77 |
| Distribution | Worldwide Distribution to the countries of : Australia, Canada, Germany, France, Great Britain, Hong Kong, and Ireland |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K915270 | PATIENT CONTROLLED SYRINGE PUMP TYPE 3300 Graseby Medical , Ltd., Aug 24, 1992 |