Device product
PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746
Z-2461-2018
Product summary
- Firm
- Ethicon, Inc.
- Event
- Event 80306
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4440
- Official record key
device-enforcement:Z-2461-2018
Official wording
Reason: 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.
Code information: KDH782 KEH344 KEJ158 KGJ668 KGQ354 KJE929 KJH424 KKJ658 LAB267 LCH376 LCH571 LEB803 LGB860 LKR893 LPJ096 LPP510 MCJ449 MCQ993
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.
Derived failure modes
-
Device software or design
design issue
-
Labeling or packaging
packaging design issue
-
Sterility assurance
breach of sterility