B. Braun Medical, Inc.: 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.

Recall number

Z-1992-2012

Recalling firm

B. Braun Medical, Inc.

Product

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.

Status

Terminated

Initiated

2012-03-23

Posted

2012-07-16

Terminated

2014-11-03

Reason

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

Root cause

Device Design

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.

Quantity

38,225 pumps

Distribution

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.

Lot, serial or model codes

Pump Model Numbers: 8713050U, 8713050U-99, 8713050US, 8713060U, and 8713060U-99 -- various serial numbers.

510(k) numbers

["K062700","K083689"]

PMA numbers

not on file

Product code

FRN

Firm FEI

2523676

Firm city

Allentown

Firm state

PA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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