FDA Device recall Z-2461-2018
PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746
- FDA Device
- Class II
- terminated
- Published 2018-07-25
On 2018-07-25 the FDA classified a Class II recall of PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746 by Ethicon, citing 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 cau….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2461-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-05-07 |
| Published | 2018-07-25 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ethicon |
| Distribution | 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 |
Product
PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746
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.
Identifiers
| code_info | KDH782 KEH344 KEJ158 KGJ668 KGQ354 KJE929 KJH424 KKJ658 LAB267 LCH376 LCH571 LEB803 LGB860 LKR893 LPJ096 LPP510 MCJ449 MCQ993 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2461-2018%22
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