Ethicon recalls PROLE:NE Suture 36" (90cm) 4-0 Blue (D9067) due to packaging perforation risk causing soft tissue injury or infection. Affected products include specific codes.
The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional.
Ethicon is recalling PROLENE Suture 36" (90cm) 4-0 Blue (D9067) because the packaging may perforate, risking soft tissue injury to healthcare workers or patient infections. This is a safety issue for medical professionals using the product.
The suture packaging design can perforate, potentially causing soft tissue injury to healthcare workers or patient infections if the breach goes unnoticed. This happens because the packaging is not sealed properly under normal use conditions.
Healthcare professionals and patients using the recalled suture product are at risk. The risk is highest for those handling the product without proper checks for packaging integrity.
Check for the product code D9067 on the packaging. The suture is 36" (90cm) 4-0 Blue with specific codes: KKJ659, LAH044, LEH699, MCH331, MDH290, MCQ536.
Inspect the packaging for perforations before use. If perforated, do not use the product.
The product may pose a risk of soft tissue injury or infection if the packaging perforates. Always check for perforations before use.
Check the packaging for perforations. If perforated, do not use it. Contact Ethicon for further guidance.
Look for the product code D9067 with specific codes: KKJ659, LAH044, LEH699, MCH331, MDH290, MCQ536 on the packaging.
We’ve drafted a message you can send Ethicon to request your refund or repair — edit it as you like.
Subject: Recall Z-2459-2018 — Ethicon Ethicon Hello, I own a Ethicon that is covered by recall Z-2459-2018 from Ethicon. 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.
