Ethicon recalls PROLENE Suture 36" 4-0 Blue (D7768) due to packaging perforation risk. Perforated packaging may cause soft tissue injury or patient infection if sterility is breached.
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" 4-0 Blue (D7768) because the packaging can perforate, potentially causing injury to healthcare workers or infections in patients if sterility is compromised.
The suture packaging has a design flaw that can cause it to perforate. If the packaging tears, it may lead to soft tissue injury for healthcare workers or patient infections if the breach goes unnoticed.
Healthcare professionals and patients using this 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 D7768 on the packaging. This suture is sold under specific model numbers including KDH099, KDJ422, KDJ564, and others listed in the recall notice.
Inspect the packaging for perforations before use. If the package is damaged, stop using the product immediately.
The recall indicates a potential risk of packaging perforation, which could cause injury or infection. Use only unperforated packaging as directed.
Affected models include D7768 and specific codes like KDH099, KDJ422, KDJ564, KEB962, KEE491, KEE541, KKH770, KKJ554, KKJ555, KKJ688, KMB434, KMP958, KPH281, KPP708, KPP709, LBJ626, LCH208, LDH331, LEP836, LGB696, LGP653, LHB978, LHH617, LJE597, LKH051, LMH352, LPJ187, LPJ672, LPP509, MCJ330, MCJ448, MDH289, MCQ533.
The recall does not specify a return process. Check packaging for perforations and stop use if damaged.
We’ve drafted a message you can send Ethicon to request your refund or repair — edit it as you like.
Subject: Recall Z-2453-2018 — Ethicon Ethicon Hello, I own a Ethicon that is covered by recall Z-2453-2018 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
