FDAFDA · Food and drugs·Recall number Z-2448-2018
PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
Published July 25, 2018 · Recall initiated: May 7, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ethicon, Inc.
- Distributor
- 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.
- Lot
- KDJ805 KDP827 LBB354 MAP602
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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