Recall Z-0497-2018— Smiths Medical ASD Inc.

Name: FDA recall Z-0497-2018
Creator: U.S. Food and Drug Administration
Published: 2017-08-24

Class II · Terminated

Class II FDA medical device recall by Smiths Medical ASD Inc., initiated 2017-08-24, terminated 2020-05-01. It names one FDA 510(k) clearance: K915270. 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..

Recalling firm: Smiths Medical ASD Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-08-24
Terminated: 2020-05-01
Firm location: Minneapolis, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K915270 — PATIENT CONTROLLED SYRINGE PUMP TYPE 3300Graseby Medical , Ltd.·cleared 1992-08-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.