Halyard AORTA PACK Surgical Kit Recalled for Loose Metal Flakes
Halyard AORTA PACK surgical kits are recalled because sponge forceps and towel clamps may contain loose metal flakes that could enter a patient's surgical site, causing local or foreign body reactions.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall addresses potential contamination of surgical instruments with loose metal flakes that could enter a patient's surgical site. Although this presents a risk of local reactions or foreign body reactions, no illnesses or injuries have been reported. Per the FDA severity rubric, risk-of-harm products without reported injury are classified as High.
Plain-English summary
AVID Medical, Inc. is recalling the Halyard AORTA PACK (Model ESJH004-02), a medical convenience kit for surgical use. The kit is distributed nationwide across the United States, with lot number 1585536.
The recall involves sponge forceps and towel clamps that may contain small loose metal flakes. These flakes could potentially detach from the components and enter a patient's surgical site undetected, potentially causing local reactions or foreign body reactions.
The recalled product
- Product
- Halyard AORTA PACK - Medical convenience kits Model Number: ESJH004-02
- Manufacturer
- AVID Medical, Inc.
- Category
- Medical Device — Surgical Kit
- Hazard
- metal-contamination
- foreign-body
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- GTIN: 10809160355770 Lot Number: 1585536
Distribution
Distributed nationwide across the United States.
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