Z-1876-2018 Class II Terminated
FDA device recall Z-1876-2018 was initiated by Nipro Medical Corporation on Dec 19, 2017 and is designated Class II. Reason for recall: There is a possibility of the heparin line is occluded. The recall status is terminated (terminated Oct 19, 2021). Affected quantity: 307,944 units.
Recall details
- Product Type
- Devices
- Report Date
- May 23, 2018
- Initiation Date
- Dec 19, 2017
- Termination Date
- Oct 19, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 307,944 units.
Product description
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 access to the patient s blood during hemodialysis. The compatibility of available configurations is the responsibility of the physician in charge.
Reason for recall
There is a possibility of the heparin line is occluded.
Distribution pattern
US Distribution to the states of : GA, NY, TN, TX.
Code information
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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1876-2018
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026