FDA Device recall Z-0497-2018
Graseby 3300 Pump and Graseby 3000 Series Pump Accessories Patient controlled syringe pump
- FDA Device
- Class II
- terminated
- Published 2018-02-07
On 2018-02-07 the FDA classified a Class II recall of Graseby 3300 Pump and Graseby 3000 Series Pump Accessories Patient controlled syringe pump by Smiths Medical Asd, citing in certain cases, the lock and key supplied with Graseby 3300 pumps and accessories does not match the standard Graseby 3300 key.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0497-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-08-24 |
| Published | 2018-02-07 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Smiths Medical Asd |
| Distribution | n/a |
Product
Graseby 3300 Pump and Graseby 3000 Series Pump Accessories Patient controlled syringe pump. Use for Infusion
Reason
In certain cases, the lock and key supplied with Graseby 3300 pumps and accessories does not match the standard Graseby 3300 key.
Identifiers
| code_info | Model: 0128-0001, 0128-0025, 0128-0135, 0128-0136, and 0128-0451 Lot/Serial #'s: 1074,8305,8718, 11325, 11540, 16230,…Model: 0128-0001, 0128-0025, 0128-0135, 0128-0136, and 0128-0451 Lot/Serial #'s: 1074,8305,8718, 11325, 11540, 16230, 32982, 34076, 42678, 52734, 55337, 60959, 60965, 64104, 67638, 68079, 69199, 72740, 90734, 100817, 12001289, 12001409, 12001557, 12001612, 12008230, 004325, 008303, 012348, 018148, 032159, 041927, 048278, 054171, and 069850 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0497-2018%22
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