—#109869

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.

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K062700, K083689
Affected lot / code info: Pump Model Numbers: 8713050U, 8713050U-99, 8713050US, 8713060U, and 8713060U-99 -- various serial numbers.

Why it was recalled

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 (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: B. Braun Medical, Inc.
Address: 901 Marcon Boulevard, Allentown, Pennsylvania 18109-9512

Distribution

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.

Timeline

Recall initiated: 2012-03-23
Posted by FDA: 2012-07-16
Terminated: 2014-11-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #109869. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.