Z-3151-2026 Class I Ongoing
FDA device recall Z-3151-2026 was initiated by AVID Medical, Inc. on August 10, 2026 and is designated Class I. Reason for recall: Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical. The recall status is ongoing. Affected quantity: 1640 kits.
Recall Details
- Product Type
- Devices
- Report Date
- September 23, 2026
- Initiation Date
- August 10, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1640 kits
Product Description
Haylard 18G SINGLE SHOT EPI TRAY; Model/Item Number (Kit): DPGE002-02;
Reason for Recall
Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.
Distribution Pattern
Domestic: IL, NC, VA, WY;
Code Information
Model/Item Number (Kit): DPGE002-02; UDI-DI: 10809160410325; Kit Lots: 1641713, 1641714, 1659697, 1668209; Recalled Sodium Chloride Ampule Lot: AB4003;