Z-2449-2018 Class II Terminated
FDA device recall Z-2449-2018 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: 1728.
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
- 1728
Product Description
PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
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
KGJ667 KJJ690 KMH714 KPP499 LBJ528 LCJ143 LPJ095 MDH288
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2449-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026