NIPRO SET / SLIMLINE BLOOD TUBING SET for Hemodialysis with Transducer Protectors and Priming Set A disposable bloodline
FDA device recall Z-0624-2016 · posted 2016-01-08 · Terminated
Recall details
- Recalling firm
- Nipro Medical Corporation
- Reason for recall
- Blood foaming was found during evaluation of the product.
- Action taken
- NIPRO contacted their consignees by email 9/25/2013 of the affected product. Customers were instructed to return product back to Nipro Medical Warehouse or discard at point of use. Please contact Director of QA/RA at Nipro Medical Corporation for any additional information or return correspondence to JessicaO@nipromed.com / 305.599.7174x249.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- FJK
- Quantity affected
- 1,484 pieces.
- Distribution
- US Distribution to states of: TN and NJ.
- Date initiated
- 2015-03-30
- Date posted
- 2016-01-08
- Date terminated
- 2016-02-04
- Location
- Miami, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET (K112628) | Nipro Medical Corporation | 2012-09-28 |