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Recall Observatory FDA recall evidence

Device 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.

Z-0623-2013

March 23, 2012

Class II

Product summary

Firm
B. Braun Medical, Inc.
Event
Event 63862
Status
Terminated
Classification
Class II
Quantity
13,078
Official record key
device-enforcement:Z-0623-2013

Official wording

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

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.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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