Z-2450-2018 Class II Terminated
FDA device recall Z-2450-2018 was initiated by Ethicon, Inc. on May 7, 2018 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated Jun 8, 2020). Affected quantity: 4452.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 25, 2018
- Initiation Date
- May 7, 2018
- Termination Date
- Jun 8, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4452
Product Description
PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
Reason for Recall
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.
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.
Code Information
KEB377 KEH280 KGP662 KMJ048 KPP500 LCH042 LHP301 LJE786 LPB869 MAH170 MCH330 MCQ992
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2450-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026