Recall Z-0161-2013 ยท MEB Pump, Infusion, Elastomeric
First Medical Source LLC
Medpro Elastomeric Infusion Pump. AccuFlux, Model # CT-0020-100H. Product Usage: The devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites or epidural administration of medications. It is the responsibility of the user to ensure that the medication is prepared and administered accordance with the drug manufacturers package insert. The device
| Date | Oct 30, 2012 (initiated Jul 9, 2011) |
| Status | Terminated |
| Reason | Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being reclassified by the Agency as a Class I. The recall was initiated because First Medical Source has confirmed that these lots may have a higher flow rate than specified. The use of this product may lead to over-administration of drug solutions to the patients. The pr |
| Root cause | Nonconforming Material/Component |
| Action | Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being reclassified by the Agency as a Class I. First Medical Source received an email from Medpro International with the following lnstruction to Customer - Informed customers to remove product from sales/discontinue use, cease distribution, remove the products from inventory and quarantine, inform their customers to retum the unused products to them, and destroy the product. Distributors' customer service will contact the customer to coordinate the return of the good |
| Quantity | 500 units |
| Distribution | US Nationwide distribution in the state of IL |
| 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 |