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Recall Observatory FDA recall evidence

Device product

PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746

Z-2461-2018

May 07, 2018

Class II

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

    reason.device_software_design · v1.0.0

    design issue
  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    packaging design issue
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    breach of sterility