Nipro Safe Touch TULIP Safety Fistula Needle, FT+152530TP, for use as a blood access device for blood purification and f
FDA device recall Z-0161-2016 · posted 2015-10-23 · Terminated
Recall details
- Recalling firm
- Nipro Medical Corporation
- Reason for recall
- Some 1 1/4" needles were packaged and labeled in the 1" blister package.
- Action taken
- Customers were issued a RMA 60001203 on August 18, 2015.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- LLB
- Quantity affected
- 50,000 pieces
- Distribution
- Indiana
- Date initiated
- 2015-08-13
- Date posted
- 2015-10-23
- Date terminated
- 2017-10-13
- Location
- Miami, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NIPRO SAFETOUCH TULIP SAFETY FISTULA NEEDLE (K071145) | Nipro Medical Corporation | 2007-09-07 |