Z-0623-2013Class II

Space Pump Pole Clamps for the Infusomat Space Pump, model number 8713130. The Pole Clamp is an accessory to...

Name: Z-0623-2013 Space Pump Pole Clamps for the Infusomat Space Pump, model number 8713130. The Pole Clamp is an accessory to...
Creator: B. Braun Medical, Inc.
Published: 2012-03-23
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2012-03-23 / Terminated / root cause: design

FDA source

B. Braun Medical, Inc. began a recall of Space Pump Pole Clamps for the Infusomat Space Pump, model number 8713130. The Pole Clamp is an accessory to Space Pumps designed to support 1 to 3 pumps on a... on 2012-03-23. FDA classified it as Class II and gives the reason as "Firm has become aware of the potential for breakage of the pole clamp locking grids, or rasters, in the Space Pole Clamps". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0623-2013
Classification: Class II
Status: Terminated
Initiated: 2012-03-23
Posted: 2012-12-31
Terminated: 2015-02-02
Recalling firm: B Braun Medical Inc
Product: Space Pump Pole Clamps for the Infusomat Space Pump, model number 8713130. The Pole Clamp is an accessory to Space Pumps designed to support 1 to 3 pumps on a pole.
Product code: FRN Pump, Infusion
Reason for recall: Firm has become aware of the potential for breakage of the pole clamp locking grids, or rasters, in the Space Pole Clamps.
Root cause tag: design
FDA root cause: Device Design
Action: B. Braun Medical, Inc sent an Urgent Medical Device letter dated March 23, 2012 , to all affected customers. The letter identified the product the problem and the action needed by the customer to take. B. Braun has implemented an improvement to the pump locking mechanism of t he older style pole clamps and will be upgrading any older style pole clamps that may remain within your facility. Please return the completed form from attachment 1 in the self-addressed envelope provided or fax the form to (610) 849-1197 within two (2) weeks of receipt\. If you require any additional information or have any questions, comments or concerns please contact your B. Braun Medical Customer Service at 800-627-7867.
Quantity in commerce: 13,078
Distribution: Worldwide Distribution--US (nationwide) including the states of AL, AZ, NC and TN.
Product codes and lots: Model number 8713130 and lot numbers 209, 309, 409, 509, 809, 909, 60939747, 60943679, 60945966, 60948966, 60959578, 60960830, 60962412, 61170378, 5048020067, 5048805107, 5048920117, 5049152127, 5049484028, 5049545028, 5049614028, 5049704038, 5049788048, 5049821048, 5050123058, 5050297068, 5050385078, 5051802039, 5051879039, 5051893059, 5051940049, 5051999049, 5052519099, 5052638099, 5052690109, 5052692109, 5052711109, 5052726119, 5052788119, 5052920119, 5053045129, 5053112010, 5053129129, 5053146010, 5053207010, 5053269020, 5053449020, 5053505030, 5053534040, 5053584030, 5053605040, and 5053645040.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0623-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0623-2013	Class II	Terminated	Voluntary: Firm initiated	2013-01-09	2012-12-31

Product code FRN

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)