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.
FDA Recall Z-0623-2013 · Posted 2012-12-31
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Recalling FirmB. Braun Medical, Inc.
Recall StatusTerminated
Product CodeFRN
Date Initiated2012-03-23
Date Terminated2015-02-02
Product Quantity13,078
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution--US (nationwide) including the states of AL, AZ, NC and TN.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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