Z-0921-2014Class II

B. Braun AccuFlo Elastomeric Infusion Pump 200ML/H 100 ML Generally used for delivery of antibiotic and local...

Name: Z-0921-2014 B. Braun AccuFlo Elastomeric Infusion Pump 200ML/H 100 ML Generally used for delivery of antibiotic and local...
Creator: B. Braun Medical, Inc.
Published: 2013-12-13
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2013-12-13 / Terminated / root cause: manufacturing process

FDA source

B. Braun Medical, Inc. began a recall of B. Braun AccuFlo Elastomeric Infusion Pump 200ML/H 100 ML Generally used for delivery of antibiotic and local anesthesia medications on 2013-12-13. FDA classified it as Class II and gives the reason as "Internal testing of two lots of the AccuFlo CT-2000-100 Elastomeric Infusion Pump identified flow rates which are outside the specified infusion time and may result in overly rapid infusion of medications". 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-0921-2014
Classification: Class II
Status: Terminated
Initiated: 2013-12-13
Posted: 2014-02-03
Terminated: 2014-09-03
Recalling firm: B Braun Medical Inc
Product: B. Braun AccuFlo Elastomeric Infusion Pump 200ML/H 100 ML Generally used for delivery of antibiotic and local anesthesia medications.
Product code: MEB Pump, Infusion, Elastomeric
Reason for recall: Internal testing of two lots of the AccuFlo CT-2000-100 Elastomeric Infusion Pump identified flow rates which are outside the specified infusion time and may result in overly rapid infusion of medications.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: B. Braun Medical sent an Urgent Medical Device Recall letter dated December 13, 2013 to affected customer. The letter identified the product the problem and the action needed to be taken by the customer. The letter was sent to Progressive Medical Inc., the Importer and B. Braun's sole customer. WHAT ACTIONS SHOULD I TAKE? 1. Further use and/or distribution of the affected product should be discontinued immediately. Please identify and quarantine any impacted materials in your possession. 2. Review this recall notification in its entirety and ensure that all users within your organization and any consignees your organization may have are informed of this recall. If you are a distributor, please forward this recall notice to any customers who are in receipt of the impacted product. 3. Determine your current inventory of the affected lots within your facility. Do not destroy any affected product. 4. Utilizing the attached "Recall Acknowledgement" form record the number of full cases and individual units (for any loose units or partial cases) in your possession. If you have no inventory, please indicate that you have zero (0) inventory on the "Recall Acknowledgement" form. 5. Return the completed "Recall Acknowledgement" form to B. Braun Medical Inc. Quality Assurance who will administer the recall on behalf of B. Braun Melsungen AG. The form must be e-mailed to [email protected] or faxed to (610) 849-1197 within two (2) weeks of receipt even it the inventory in your possession is zero. 6. Instructions for Credit, Replacement, Et Return: a.If you have purchased the product from a third-party and have any full cases, partial cases, or unused individual pieces in your possession please contact the seller to obtain instructions for handling these units. b.If you have purchased the product directly from B. Braun Medical Inc. and have any full cases, partial cases, or unused individual pieces of these affected products, ple
Quantity in commerce: 30, 240 units
Distribution: US Distribution one importer/wholesale distributor in MO.
Product codes and lots: Catalog #CT-2000-100lots 3H0125F151 and 3H0225F151, expiration 7/2018.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0921-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0921-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-12	2014-02-03

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)