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Terminated

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.

FDA Recall Z-0081-2012 · Posted 2011-10-24

Recall StatusTerminated
Product CodeMEB
Date Initiated2011-07-28
Date Terminated2011-12-19
Product Quantity180 units

Reason for Recall

The product may have a higher flow rate than specified resulting in over administration of drug solutions to the patients.

Firm 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].

Root Cause

Nonconforming Material/Component

Distribution Pattern

Nationwide distribution: USA including states of: FL, KY, PA, VA and WY.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

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

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