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Recall Observatory FDA recall evidence

Device product

PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768

Z-2453-2018

May 07, 2018

Class II

Product summary

Firm
Ethicon, Inc.
Event
Event 80306
Status
Terminated
Classification
Class II
Quantity
15180
Official record key
device-enforcement:Z-2453-2018

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: 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 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