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.
This recall has been terminated (originally issued December 31, 2012).
- Company
- B Braun Medical Inc
- Recall Initiated
- March 23, 2012
- Posted
- December 31, 2012
- Terminated
- February 2, 2015
- Recall Number
- Z-0623-2013
- Quantity
- 13,078
- Firm Location
- Allentown, PA
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide Distribution--US (nationwide) including the states of AL, AZ, NC and TN.
Lot / Code Info
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.
Root Cause
Device Design
Action Taken
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.