Device product
KIT, PRE OP DRAH - Product Usage: Preoperative kit used to decolonize intranasal S. aureus.
Z-3016-2020
Product summary
- Event
- Event 86178
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9,150 kits
- Official record key
device-enforcement:Z-3016-2020
Official wording
Reason: Only providing one nasal swab in our pre-operative kit instead of the 4 required for proper treatment.
Code information: Model: ORPDH5994A Lot numbers: 558357, 561502,566549, 571467, 574058. Expiration dates: Varies by kit components.
Distribution pattern: US Nationwide distribution including the state of North Carolina.
Derived failure modes
-
Unknown
Only providing one nasal swab in our pre-operative kit instead of the 4 required for proper treatment.