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Terminated

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.

FDA Recall Z-0268-2012 · Posted 2011-11-23

Recalling FirmWolf Medical Supply Inc.
Recall StatusTerminated
Product CodeMEB
Date Initiated2011-10-20
Date Terminated2012-04-25
Product Quantity8 cases (192 units)

Reason for Recall

Redi-Flo Elastomeric Infusion Pumps may have a higher flow rate than specified (more than +15%).

Firm Action

On 10/20/2011 Wolf Medical Supply Inc., customers were notified by telephone and email. Product was distributed to end users.

Root Cause

Process control

Distribution Pattern

Nationwide distribution, including Puerto Rico.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K081905ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMPWestmed, Inc. · 2008-07-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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