PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Ethicon, Inc.
- Reason for Recall:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
Product Codes/Lot Numbers:
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
Distribution:
Nationwide distribution
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2453-2018
Related Recalls
Potential for barb non-engagement.
Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.
Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.