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Terminated

Graseby 3300 Pump and Graseby 3000 Series Pump Accessories Patient controlled syringe pump. Use for Infusion

FDA Recall Z-0497-2018 · Posted None

Recalling FirmSmiths Medical ASD Inc.
Recall StatusTerminated
Product CodeMEA
Date Initiated2017-08-24
Date Terminated2020-05-01
Product Quantity77

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.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution to the countries of : Australia, Canada, Germany, France, Great Britain, Hong Kong, and Ireland

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K915270PATIENT CONTROLLED SYRINGE PUMP TYPE 3300Graseby Medical , Ltd. · 1992-08-24

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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