The Recall Desk
HighFDA (Devices)·Z-0623-2013·Announced 2013-01-09

B. Braun Recalls Infusomat Space Pump Pole Clamps Due to Breakage Risk

B. Braun Medical is recalling 13,078 Infusomat Space Pump Pole Clamps because the locking grids may break.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a structural defect (breakage) in a medical device accessory that could lead to harm, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

B. Braun Medical, Inc. is recalling 13,078 units of Space Pump Pole Clamps for the Infusomat Space Pump, model number 8713130. The pole clamps are accessories designed to support one to three pumps on a pole.

The recall was initiated because the firm became aware of the potential for breakage of the pole clamp locking grids, also known as rasters. The affected units were distributed worldwide, including nationwide distribution in the United States and specifically in the states of Alabama, Arizona, North Carolina, and Tennessee.

Consumers and healthcare facilities should check their inventory for the specific model and lot numbers listed in the recall notice. If the product is found, it should be removed from service and returned to B. Braun Medical, Inc. according to their instructions.

The recalled product

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.
Manufacturer
B. Braun Medical, Inc.
Category
Medical Device — Infusion Pump Accessories
Hazard
Affected units
13,078

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

The notice also names 4 states specifically:

Related recalls

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