IV Administration Sets Potential Backflow and Occlusion Risk
B. Braun is correcting gravity and pump administration sets used with specific infusion pumps due to risk of medication backflow from secondary containers into primary containers and occlusion during priming.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II voluntary correction with no reported illnesses or injuries; the hazard involves potential for backflow and occlusion during use, which are equipment-use risks. No injuries or hospitalizations are documented in the source text.
Plain-English summary
B. Braun Medical, Inc. is issuing a voluntary urgent medical device correction for gravity IV administration sets and pump administration sets designed for use with B. Braun's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump.
The correction was initiated because of a potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connections, as well as the possibility of occlusion during the priming process.
Affected units include Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433, with lot numbers 204612, 206723, 210211, 213641, 216064, 222060, 224073, 225012, 236012, and 236910. A total of 475 units were distributed nationwide to facilities in Georgia, Oregon, Tennessee, and Washington.
Customers who have received affected units should contact B. Braun Medical or Windstone Medical Packaging, Inc. for instructions on the correction procedure.
The recalled product
- Product
- Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433
- Manufacturer
- Windstone Medical Packaging, Inc.
- Affected units
- 475
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 (1)
- UDI-DI: B098AMS144330
Distribution
Part of a larger recall action
This product is one of 3 recalled by Windstone Medical Packaging, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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