MiniLoc Safety Infusion Set Winged without Y-Injection Site. Product Code: S02022-75. Packaged as single units in thermo
FDA device recall Z-0985-2017 · posted 2017-01-10 · Terminated
Recall details
- Recalling firm
- Bard Access Systems
- Reason for recall
- Bard Access Systems announces a voluntary field action for the SafeStep Huber Needle Set with Y-Injection Site and MiniLoc Safety Infusion Set Winged without Y-Injection Site devices because sets may contain one or more units where the needle length and gage differs from the length and gage described on the label.
- Action taken
- Bard sent an Urgent Notification letter dated December 16, 2016 to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to identify and return affected product. For questions call 1-800-290-1689.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 7,200 units
- Distribution
- Worldwide Distribution - US Nationwide in the states of CA, CO, FL, GA, HI, IL, MA, MD, NJ, OH, OR, TX.
- Date initiated
- 2016-12-19
- Date posted
- 2017-01-10
- Date terminated
- 2017-04-17
- Location
- Salt Lake City, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MINILOC SAFETY INFUSION SET (K050600) | Specialized Health Products, Intl. | 2005-05-12 |