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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls

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 Class 1 Recall
Medpro AccuFlo Elastomeric Infusion Device
see related information
Date Posted October 24, 2011
Recall Number Z-0081-2012
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.
Code Information Lot #100924, Exp. 2015-08, Item CT-0020-270C
Recalling Firm/
Manufacturer
Progressive Medical Inc
11085 Gravois Industrial Ct
Saint Louis, Missouri 63128-2012
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Mark M. Martin
314-961-5786
Reason for
Recall
The product may have a higher flow rate than specified resulting in over administration of drug solutions to the patients.
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 dsullivan@progressivemedinc.com.
Quantity in Commerce 180 units
Distribution Nationwide distribution: USA including states of: FL, KY, PA, VA and WY.
 
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