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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
- 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
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