Device product
PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
Z-2449-2018
Product summary
- Firm
- Ethicon, Inc.
- Event
- Event 80306
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1728
- Official record key
device-enforcement:Z-2449-2018
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: KGJ667 KJJ690 KMH714 KPP499 LBJ528 LCJ143 LPJ095 MDH288
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