—#114927

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.

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K062700, K083689
Affected 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.

Why it was recalled

Firm has become aware of the potential for breakage of the pole clamp locking grids, or rasters, in the Space Pole Clamps.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution--US (nationwide) including the states of AL, AZ, NC and TN.

Timeline

Recall initiated: 2012-03-23
Posted by FDA: 2012-12-31
Terminated: 2015-02-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #114927. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.