Recall Z-0081-2012 ยท MEB Pump, Infusion, Elastomeric
Progressive Medical Inc
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.
| Date | Oct 24, 2011 (initiated Jul 28, 2011) |
| Status | Terminated |
| Reason | The product may have a higher flow rate than specified resulting in over administration of drug solutions to the patients. |
| 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. |
| Quantity | 180 units |
| Distribution | Nationwide distribution: USA including states of: FL, KY, PA, VA and WY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081905 | ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP Westmed, Inc., Jul 15, 2008 |