Sterling Nitrile Sterile Powder Free Exam Gloves, S, Sterile.
FDA device recall Z-0758-2017 · posted 2016-12-14 · Terminated
Recall details
- Recalling firm
- Halyard Health
- Reason for recall
- Defects: Product may be discolored and brittle resulting in the inability of the user to don the gloves without tearing.
- Action taken
- Consignees were notified by letter via Fed Ex on/about 11/10/2016.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- LZA
- Quantity affected
- 59 cases
- Distribution
- CA, FL, GA, IA, IN, LA, MA, MN, MT, NM, OR, TX and UT.
- Date initiated
- 2016-11-10
- Date posted
- 2016-12-14
- Date terminated
- 2017-05-04
- Location
- Roswell, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| KIMBERLY-CLARK STERLING NITRILE POWDER-FREE EXAM GLOVE (STERILE) (K081027) | Kimberly-Clark Corp. | 2008-06-30 |