Device product
20" 2-Needle 26-Gauge 6mm HlgH-Flo Subcutaneous Safety Needle Sets" Product # RMS22606 - Product Usage: RMS HlgH-Flo Subcutaneous Safety Needle Sets are intended for the delivery of medication to the subcutaneous tissue.
Z-0051-2020
Product summary
- Event
- Event 83650
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1990 pouches
- Official record key
device-enforcement:Z-0051-2020
Official wording
Reason: Mislabeled needle lengths
Code information: Lot # N.78648 GTIN: 00659443000292
Distribution pattern: US Nationwide distribution including the states of NJ, OH, FL, GA, IL, MA, CA, TX, NC, IA, NV, OR, MD, TN, VA, NY.
Derived failure modes
-
Labeling or packaging
Mislabeled