AVID Medical recalls Halyard OPEN HEART PACK MAIN medical kits with model ESJH003-02 due to potential metal flakes causing surgical site reactions. Affected units sold from 2021-07-01 to 2021-07-01.
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
AVID Medical is recalling Halyard OPEN HEART PACK MAIN medical kits (model ESJH003-02) because small metal flakes could detach and enter surgical sites, causing reactions or infections. This is serious for patients undergoing surgery.
Metal flakes from the sponge forceps and towel clamps can detach during surgery. If these flakes enter the surgical site, they may cause local reactions or foreign body reactions that could lead to infection.
Patients using this medical kit during surgery are most at risk. The affected product was sold from July 1, 2:00 PM to July 1, 2:00 PM, 2021.
Check for the model number ESJH003-02 on the Halyard OPEN HEART PACK MAIN kit. The product was sold from July 1, 2021.
Immediately stop using the Halyard OPEN HEART PACK MAIN kit if you have it.
No, the product has a risk of metal flakes causing surgical site reactions, so it should be stopped immediately.
Stop using it now and contact AVID Medical for instructions.
The product was sold from July 1, 2021.
We’ve drafted a message you can send AVID Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0387-2025 — AVID Medical AVID Medical Hello, I own a AVID Medical that is covered by recall Z-0387-2025 from AVID Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
