Z-0161-2013Class I

Medpro Elastomeric Infusion Pump. AccuFlux, Model # CT-0020-100H

Name: Z-0161-2013 Medpro Elastomeric Infusion Pump. AccuFlux, Model # CT-0020-100H
Creator: First Medical Source LLC
Published: 2011-07-09
License: https://open.fda.gov/license/

First Medical Source LLC / initiated 2011-07-09 / Terminated / root cause: manufacturing process

FDA source

First Medical Source LLC began a recall of Medpro Elastomeric Infusion Pump. AccuFlux, Model # CT-0020-100H. Product Usage: The devices are intended for patients requiring intravenous, percutaneous... on 2011-07-09. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0161-2013
Classification: Class I
Status: Terminated
Initiated: 2011-07-09
Posted: 2012-10-30
Terminated: 2014-09-22
Recalling firm: First Medical Source LLC
Product: 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 devices deliver controlled amounts of medication directly to the intraoperative site for pain management and or antibiotic administration. The devices infuse the medication at an hourly flow rate. Medications are infused intraoperatively and postoperatively through intramuscular or subcutaneous routes. The devices are also intended for controlled delivery of local anesthetics in close proximity to nerves for post operative regional anesthesia and pain management. Routes of administration may be intraoperative or percutaneous. It is for continuous infusion of medications for general infusion use, including antibiotic delivery and chemotherapy.
Product code: MEB Pump, Infusion, Elastomeric
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
Root cause tag: manufacturing process
FDA 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 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.
Quantity in commerce: 500 units
Distribution: US Nationwide distribution in the state of IL
Product codes and lots: AccuFlux, Lot#: 91209.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0161-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0161-2013	Class I	Terminated	Voluntary: Firm initiated	2012-12-05	2012-11-27

Product code MEB

K081905Class IIAccuflow and Accuflux Elastomeric Infusion PumpWestmed, Inc. / cleared 2008-07-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)