Medpro Elastomeric Infusion Pump. AccuFlux, Model # CT-0020-100H. Product Usage: The devices are intended for patients r

FDA device recall Z-0161-2013 · posted 2012-10-30 · Terminated

Recall details

Recalling firm

First Medical Source LLC

Reason for recall

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

Action taken

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 goods in question where required. First Medical Source emailed to their customer, Williams Medical Technologies, to informed them of the recall of the Medpro Elastomeric infusion pumps. Customer was instructed to inform them of the date and method of disposal of recalled products.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

MEB

Quantity affected

500 units

Distribution

US Nationwide distribution in the state of IL

Date initiated

2011-07-09

Date posted

2012-10-30

Date terminated

2014-09-22

Location

Laguna Beach, CA

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