—#160935

Product

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

FDA product code: MEA — Pump, Infusion, Pca
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K915270
Affected lot / code info: 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

Why it was recalled

In certain cases, the lock and key supplied with Graseby 3300 pumps and accessories does not match the standard Graseby 3300 key.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Smiths Medical ASD Inc.
Address: 6000 Nathan Ln N, Minneapolis, Minnesota 55442-1690

Distribution

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

Timeline

Recall initiated: 2017-08-24
Terminated: 2020-05-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #160935. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.