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Terminated

Infusomat(R) Space Pump (US Version) with software version 686G030103 (commonly termed 'G03'), 686E030003, 686F030005, 686F030007, 686G030002, and 686G030102. Intended for use with adults, pediatrics and neonates and is intended to provide infusions of parenteral fluids/medications, blood and blood products indicated for infusion through FDA approved routes of administration.

FDA Recall Z-1992-2012 · Posted 2012-07-16

Recalling FirmB. Braun Medical, Inc.
Recall StatusTerminated
Product CodeFRN
Date Initiated2012-03-23
Date Terminated2014-11-03
Product Quantity38,225 pumps

Reason for Recall

Firm became aware of the potential for breakage of the anti free flow clip catch, located on the inside of the pump door, when the IV set anti free flow clip is incorrectly inserted into the pump and the pump door forced closed. If the clip catch is broken and the door opened, free flow protection is still ensured. However, after the set is manually removed from the pump without the closure of t

Firm Action

B. Braun Medical, Inc. sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated March 23, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to identify the affected product in their inventory and to complete and return the Product Acknowledgement Form via fax to (610)849-1197. Contact the Customer Support Department at (800) 626-7867 for assistance with returning any product or if you have questions regarding this notice.

Root Cause

Device Design

Distribution Pattern

Nationwide Distribution-including Puerto Rico and the states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NV, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, TN, TX, VT, VA, WA, WV, and WI.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K083689INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEMB.Braun Medical, Inc. · 2009-07-01K062700INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEMB.Braun Medical, Inc. · 2006-10-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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