AVID Medical recalls Halyard CPT EP PACK medical kits with model SHAN442-04 due to potential metal flakes causing surgical site reactions. Affected units sold in 2016.
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 CPT EP PACK medical kits (model SHAN442- 04) because small metal flakes could detach and enter surgical sites, causing reactions. This poses a risk to patients during surgery.
Small metal flakes from the sponge forceps and towel clamps might detach during use. If these flakes enter a patient's surgical site, they could cause local reactions or foreign body reactions.
Healthcare professionals using these kits during surgery are most at risk. Patients undergoing procedures with these kits could experience surgical site reactions.
Check for model number SHAN442-04 on the Halyard CPT EP PACK medical kits. Units were sold with lot number 1608261 in 2016.
Look for model number SHAN442-04 on the Halyard CPT EP PACK medical kits.
Yes, metal flakes could enter surgical sites causing reactions, but the remedy isn't specified in the recall notice.
Check for model number SHAN442-04 on the Halyard CPT EP PACK medical kits. Units were sold with lot number 1608261 in 2016.
The recall notice doesn't specify a remedy, so contact AVID Medical for guidance.
We’ve drafted a message you can send AVID Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0434-2025 — AVID Medical AVID Medical Hello, I own a AVID Medical that is covered by recall Z-0434-2025 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.
