Z-0081-2012

Medpro AccuFlo Elastomeric Infusion Device, Model #CT-0020-270C, packaged 12/box. The box label shows the...

Name: Z-0081-2012 Medpro AccuFlo Elastomeric Infusion Device, Model #CT-0020-270C, packaged 12/box. The box label shows the...
Creator: Progressive Medical Inc
Published: 2011-07-28
License: https://open.fda.gov/license/

Progressive Medical Inc / initiated 2011-07-28 / Terminated / root cause: manufacturing process

FDA source

Progressive Medical Inc began a recall of Medpro AccuFlo Elastomeric Infusion Device, Model #CT-0020-270C, packaged 12/box. The box label shows the product is Manufactured By: Medpro International... on 2011-07-28. The reason FDA records is "The product may have a higher flow rate than specified resulting in over administration of drug solutions to the patients". 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-0081-2012
Status: Terminated
Initiated: 2011-07-28
Posted: 2011-10-24
Terminated: 2011-12-19
Recalling firm: Progressive Medical Inc
Product: Medpro AccuFlo Elastomeric Infusion Device, Model #CT-0020-270C, packaged 12/box. The box label shows the product is Manufactured By: Medpro International (Thailand) Ltd. for Medpro Corporation Pte. Ltd., Singapore. The devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites or epidural administration of medications.
Product code: MEB Pump, Infusion, Elastomeric
Reason for recall: The product may have a higher flow rate than specified resulting in over administration of drug solutions to the patients.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm, Progressive Medical, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated July 28, 2011 via email and regular mail to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to discontinue their use; remove the products from inventory and quarantine them; inform their customers to return unused products to Progressive; return the product, and complete and return the RECALL RETURN RESPONSE FORM via fax to 314-961-5786. Progressive customer service will contact the customers to coordinate the return of the goods in question. Should you have any questions, please call 800-969-6331 or email to [email protected].
Quantity in commerce: 180 units
Distribution: Nationwide distribution: USA including states of: FL, KY, PA, VA and WY.
Product codes and lots: Lot #100924, Exp. 2015-08, Item CT-0020-270C

Product code MEB

K081905Class IIAccuflow and Accuflux Elastomeric Infusion PumpWestmed, Inc. / cleared 2008-07-15

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)