Z-0497-2018Class II

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

Name: Z-0497-2018 Graseby 3300 Pump and Graseby 3000 Series Pump Accessories Patient controlled syringe pump. Use for Infusion
Creator: Smiths Medical ASD Inc.
Published: 2017-08-24
License: https://open.fda.gov/license/

Abbott Medical / initiated 2017-08-24 / Terminated / root cause: manufacturing process

FDA source

Smiths Medical ASD Inc. began a recall of Graseby 3300 Pump and Graseby 3000 Series Pump Accessories Patient controlled syringe pump. Use for Infusion on 2017-08-24. FDA classified it as Class II and gives the reason as "In certain cases, the lock and key supplied with Graseby 3300 pumps and accessories does not match the standard Graseby 3300 key". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0497-2018
Classification: Class II
Status: Terminated
Initiated: 2017-08-24
Posted: 2018-02-01
Terminated: 2020-05-01
Recalling firm: Abbott Medical
Product: Graseby 3300 Pump and Graseby 3000 Series Pump Accessories Patient controlled syringe pump. Use for Infusion
Product code: MEA Pump, Infusion, Pca
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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.
Quantity in commerce: 77
Distribution: Worldwide Distribution to the countries of : Australia, Canada, Germany, France, Great Britain, Hong Kong, and Ireland
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0497-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0497-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-02-01

Product code MEA

K915270Class IIPatient Controlled Syringe Pump Type 3300Graseby Medical , Ltd. / cleared 1992-08-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)