B. Braun Infusomat Space Pump Recall for Anti-Free Flow Clip Defect
B. Braun Medical is recalling 38,225 Infusomat Space Pumps because the anti-free flow clip catch may break if the IV set is inserted incorrectly.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Firm became aware of the potential for breakage of the anti free flow clip catch, located on the inside of the pump door, when the IV set anti free flow clip is incorrectly inserted into the pump and the pump door forced closed. If the…"
Plain-English summary
B. Braun Medical, Inc. is recalling 38,225 Infusomat Space Pumps (US Version) with specific software versions. The affected pumps are intended for use with adults, pediatrics, and neonates to provide infusions of parenteral fluids, medications, and blood products. The recall covers pump model numbers 8713050U, 8713050U-99, 8713050US, 8713060U, and 8713060U-99 with various serial numbers.
The recall was initiated because the firm became aware of the potential for the anti-free flow clip catch, located on the inside of the pump door, to break. This breakage can occur if the IV set anti-free flow clip is incorrectly inserted into the pump and the pump door is forced closed. The source text notes that if the clip catch is broken and the door is opened, free flow protection is still ensured, but the text is truncated regarding the consequences of manually removing the set without door closure.
The affected pumps were distributed nationwide, including Puerto Rico and the states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NV, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, TN, TX, VT, VA, WA, WV, and WI. The source text does not specify instructions for consumers or healthcare providers on how to proceed with the recall.
The recalled product
- Product
- Infusomat(R) Space Pump (US Version) with software version 686G030103 (commonly termed 'G03'), 686E030003, 686F030005, 686F030007, 686G030002, and 686G030102. Intended for use with adults, pediatrics and neonates and is intended to provide infusions of parenteral…
- Manufacturer
- B. Braun Medical, Inc.
- Category
- Medical Device — Infusion Pump
- Affected units
- 38,225
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 (5)
- Pump Model Numbers: 8713050U
- 8713050U-99
- 8713050US
- 8713060U
- and 8713060U-99 -- various serial numbers.
Distribution
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