Graseby 3300 Pump and Graseby 3000 Series Pump Accessories Patient… — Class II medical device recall Z-0497-2018
Terminated recall by Smiths Medical ASD Inc., reported 2018-02-07. In certain cases, the lock and key supplied with Graseby 3300 pumps and accessories does not match the standar
| Recall number | Z-0497-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smiths Medical ASD Inc., Minneapolis, MN, United States |
| Recall initiated | 2017-08-24 |
| Classified | 2018-02-01 |
| Reported by FDA | 2018-02-07 |
| Terminated | 2020-05-01 |
| Countries outside the US | AU, CA, DE, FR, GB, HK, IE |
| Quantity | 77 |
| Serial numbers | 004325, 008303, 012348, 018148, 032159, 041927, 048278, 054171, 069850, 100817, 1074, 11325, 11540, 12001289, 12001409, 12001557, 12001612, 12008230, 16230, 32982, 34076, 42678, 52734, 55337, 60959 and 9 more |
| Model numbers | 0128-0001, 0128-0025, 0128-0135, 0128-0136, 0128-0451 |
Product
Graseby 3300 Pump and Graseby 3000 Series Pump Accessories Patient controlled syringe pump. Use for Infusion
Reason for recall
In certain cases, the lock and key supplied with Graseby 3300 pumps and accessories does not match the standard Graseby 3300 key.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.