Z-2453-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 25, 2018
- Initiation Date
- May 7, 2018
- Termination Date
- June 8, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15180
Product Description
PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
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.
Distribution Pattern
Accounts in AZ, CA, CO, FL, GA, IL, IN, KS, MA, MN, MO, NC, NE, NJ, NY, OH, OR, SC, SD, TN, TX, VA, WA, WI, WV.
Code Information
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