Infusomat(R) Space Pump (US Version) with software version 686G030103 (commonly termed 'G03'), 686E030003, 686F030005, 6

FDA device recall Z-1992-2012 · posted 2012-07-16 · Terminated

Recall details

Recalling firm

B. Braun Medical, Inc.

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

Action taken

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

Status

Terminated

Product code

FRN

Quantity affected

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,

Date initiated

2012-03-23

Date posted

2012-07-16

Date terminated

2014-11-03

Location

Allentown, PA

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