Nipro Blood Tubing Set Recalled Due to Potential Heparin Line Occlusion
Nipro Medical Corporation is recalling specific blood tubing sets used in hemodialysis because the heparin line may be occluded.
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 risk-of-harm product (occluded line) where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Nipro Medical Corporation is recalling Nipro Blood Tubing sets with Priming Sets and Transducer Protectors. These disposable bloodlines are intended to provide extracorporeal access to a patient's blood during hemodialysis. The recall involves 307,944 units distributed in the United States to the states of Georgia, New York, Tennessee, and Texas.
The recall is being issued because there is a possibility that the heparin line in the device is occluded. The affected devices are identified by Model No. BL+A223D/V809D and specific vendor batch numbers listed in the agency record.
Healthcare facilities and consumers should stop using the affected blood tubing sets and contact Nipro Medical Corporation for further instructions or a replacement.
The recalled product
- Product
- Nipro Blood Tubing set with Priming Set and Transducer Protectors. Each device is packaged in a film pouch with 24 lines per case. The Nipro¿ Set - Blood Tubing Set with Transducer Protector and Priming Set are disposable bloodlines intended to provide extracorporeal…
- Manufacturer
- Nipro Medical Corporation
- Hazard
- Affected units
- 307,944
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 No. BL+A223D/V809D
- Vendor Batch No. 17I06-9
- 17I16-9
- 17I18-9
- 17J17-9
- 17J19-9
- 17J20-9
- 17J21-9
- 17I19-9
- 17K07-9
- 17I01-9
- 17J12-9
- 17J16-9
- 17I21-9
- 17I25-9
- 17I26-9
- 17J09-9
- 17J11-9
- 17K15-9
- 17K16-9.
Distribution
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