Z-0268-2012

Wolf Medical Supply, Inc., WOLF-PAK REDI-FLO ELASTOMERIC INFUSION PUMP, FILL VOLUME 100 mL, FLOW RATE 2mL/Hr...

Name: Z-0268-2012 Wolf Medical Supply, Inc., WOLF-PAK REDI-FLO ELASTOMERIC INFUSION PUMP, FILL VOLUME 100 mL, FLOW RATE 2mL/Hr...
Creator: Wolf Medical Supply Inc.
Published: 2011-10-20
License: https://open.fda.gov/license/

Wolf Medical Supply Inc. / initiated 2011-10-20 / Terminated / root cause: manufacturing process

FDA source

Wolf Medical Supply Inc. began a recall of Wolf Medical Supply, Inc., WOLF-PAK REDI-FLO ELASTOMERIC INFUSION PUMP, FILL VOLUME 100 mL, FLOW RATE 2mL/Hr. Model # CT-0020-100 Item # RFC100020... on 2011-10-20. The reason FDA records is "Redi-Flo Elastomeric Infusion Pumps may have a higher flow rate than specified (more than +15%)". 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-0268-2012
Status: Terminated
Initiated: 2011-10-20
Posted: 2011-11-23
Terminated: 2012-04-25
Recalling firm: Wolf Medical Supply Inc.
Product: Wolf Medical Supply, Inc., WOLF-PAK REDI-FLO ELASTOMERIC INFUSION PUMP, FILL VOLUME 100 mL, FLOW RATE 2mL/Hr. Model # CT-0020-100 Item # RFC100020. Manufactured by Medpro International (Thailand) Ltd.
Product code: MEB Pump, Infusion, Elastomeric
Reason for recall: Redi-Flo Elastomeric Infusion Pumps may have a higher flow rate than specified (more than +15%).
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 10/20/2011 Wolf Medical Supply Inc., customers were notified by telephone and email. Product was distributed to end users.
Quantity in commerce: 8 cases (192 units)
Distribution: Nationwide distribution, including Puerto Rico.
Product codes and lots: Lot 81218 Exp 12/2011, Lot 90227 Exp 01/2012.

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)