Z-3005-2026 Class II Ongoing
FDA device recall Z-3005-2026 was initiated by AVID Medical, Inc. on July 9, 2026 and is designated Class II. Reason for recall: Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex. The recall status is ongoing. Affected quantity: 45 kits.
Recall Details
- Product Type
- Devices
- Report Date
- September 2, 2026
- Initiation Date
- July 9, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 45 kits
Product Description
Brand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK Model/Catalog Number: SAMM064-27
Reason for Recall
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
Distribution Pattern
US Nationwide distribution in the states of MS, TX.
Code Information
Lot Code: Lot Number: 1634391 UDI: 10809160439708