AVID Medical, Inc. Recall 95515
Description: Halyard KIT, SHOULDER - Medical convenience kits Model Number: ESJH014-06
AVID Medical, Inc. Recall 95515 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-0391-2025 |
Event ID | 95515 |
Event Description | Halyard KIT, SHOULDER - Medical convenience kits Model Number: ESJH014-06 |
Product Type | Devices |
Distribution | US Nationwide distribution. |
Quantity | 42 eaches |
Recall Reason | 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 |
Device Classification | 20241120 |
Device Code Info | GTIN: 10809160423226 Lot Number: 1610214 |
Center Classification Date | 20241114 |
Recall Initiation Date | 20240920 |
Recalling Firm | AVID Medical, Inc. |
Initial Notification | |
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