Z-0387-2025 Class II Ongoing
FDA device recall Z-0387-2025 was initiated by AVID Medical, Inc. on Sep 20, 2024 and is designated Class II. Reason for recall: Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing… The recall status is ongoing. Affected quantity: 114 eaches.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 20, 2024
- Initiation Date
- Sep 20, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 114 eaches
Product Description
Halyard OPEN HEART PACK MAIN - Medical convenience kits Model Number: ESJH003-02
Reason for Recall
Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
Distribution Pattern
US Nationwide distribution.
Code Information
GTIN: 10809160355725 Lot Number: 1597931
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0387-2025
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026