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U.S. Department of Health and Human Services

Class 2 Device Recall B. Braun Space Pole Clamps for the Infusomat Space Pump

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  Class 2 Device Recall B. Braun Space Pole Clamps for the Infusomat Space Pump see related information
Date Initiated by Firm March 23, 2012
Date Posted December 31, 2012
Recall Status1 Terminated 3 on February 02, 2015
Recall Number Z-0623-2013
Recall Event ID 63862
510(K)Number K062700  K083689  
Product Classification Pump Infusion - Product Code FRN
Product 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.

Code Information Model number 8713130 and lot numbers 209, 309, 409, 509, 809, 909, 60939747, 60943679, 60945966, 60948966, 60959578, 60960830, 60962412, 61170378, 5048020067, 5048805107, 5048920117, 5049152127, 5049484028, 5049545028, 5049614028, 5049704038, 5049788048, 5049821048, 5050123058, 5050297068, 5050385078, 5051802039, 5051879039, 5051893059, 5051940049, 5051999049, 5052519099, 5052638099, 5052690109, 5052692109, 5052711109, 5052726119, 5052788119, 5052920119, 5053045129, 5053112010, 5053129129, 5053146010, 5053207010, 5053269020, 5053449020, 5053505030, 5053534040, 5053584030, 5053605040, and 5053645040.
Recalling Firm/
Manufacturer		 B. Braun Medical, Inc.
901 Marcon Boulevard
Allentown PA 18109-9512
For Additional Information Contact Kimberly Paris
610-266-0500
Manufacturer 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.
FDA Determined
Cause 2		 Device Design
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.
Quantity in Commerce 13,078
Distribution Worldwide Distribution--US (nationwide) including the states of AL, AZ, NC and TN.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = B. BRAUN MEDICAL, INC.
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