Z-3016-2020 Class II Terminated
FDA device recall Z-3016-2020 was initiated by Cardinal Health 200, LLC on July 30, 2020 and is designated Class II. Reason for recall: Only providing one nasal swab in our pre-operative kit instead of the 4 required for proper treatment. The recall status is terminated (terminated April 28, 2021). Affected quantity: 9,150 kits.
Recall Details
- Product Type
- Devices
- Report Date
- October 7, 2020
- Initiation Date
- July 30, 2020
- Termination Date
- April 28, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9,150 kits
Product Description
KIT, PRE OP DRAH - Product Usage: Preoperative kit used to decolonize intranasal S. aureus.
Reason for Recall
Only providing one nasal swab in our pre-operative kit instead of the 4 required for proper treatment.
Distribution Pattern
US Nationwide distribution including the state of North Carolina.
Code Information
Model: ORPDH5994A Lot numbers: 558357, 561502,566549, 571467, 574058. Expiration dates: Varies by kit components.