Z-2655-2014Class II

B.Braun Accuflo 100ML/H 100ML Elastomeric Infusion Device. AccuFlo devices are intended for patients...

Name: Z-2655-2014 B.Braun Accuflo 100ML/H 100ML Elastomeric Infusion Device. AccuFlo devices are intended for patients...
Creator: B. Braun Medical, Inc.
Published: 2014-08-06
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2014-08-06 / Terminated / root cause: labeling and UDI

FDA source

B. Braun Medical, Inc. began a recall of B.Braun Accuflo 100ML/H 100ML Elastomeric Infusion Device. AccuFlo devices are intended for patients requiring intravenous, percutaneous, subcutaneous... on 2014-08-06. FDA classified it as Class II and gives the reason as "The primary packaging label (inner pouch label) indicates that the package contents are Catalog Item: CT-1000-250, while the secondary packaging label (outer carton label) indicates the contents are CT-1000-100. The...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2655-2014
Classification: Class II
Status: Terminated
Initiated: 2014-08-06
Posted: 2014-09-16
Terminated: 2015-01-29
Recalling firm: B Braun Medical Inc
Product: B.Braun Accuflo 100ML/H 100ML Elastomeric Infusion Device. AccuFlo devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites or epidural administration of medications.
Product code: MEB Pump, Infusion, Elastomeric
Reason for recall: The primary packaging label (inner pouch label) indicates that the package contents are Catalog Item: CT-1000-250, while the secondary packaging label (outer carton label) indicates the contents are CT-1000-100. The actual contents are a CT-1000-100.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: B. Braun Medical Inc. provided the recall notification received from B. Braun Melsungen AG to Progressive Medical Inc. who is the initial importer of the product in the U.S. market. The notification was sent via FedEx and e-mail on/about August 6, 2014 and identified the product, problem, and action to be taken. The notification indicated that if the affected units were further distributed that any distributors are required to forward the letter on to their consignees.
Quantity in commerce: 8,640 units
Distribution: Distributed in the state of Missouri.
Product codes and lots: Lot Number: 4A1125F111

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2655-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2655-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-24	2014-09-16

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)