FDA Device recall Z-1136-2019
PDS II SUTURE 18"(45CM) 2-0 VIO Product Code:Z739D - PDS Sutures are intended for use in soft tissue approximation, including use in pediat…
- FDA Device
- Class II
- terminated
- Published 2019-04-24
On 2019-04-24 the FDA classified a Class II recall of PDS II SUTURE 18"(45CM) 2-0 VIO Product Code:Z739D - PDS Sutures are intended for use in soft tissue approximation, including use in pediat… by Ethicon, citing VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does not match the sales unit carton and foil label.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1136-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-03-12 |
| Published | 2019-04-24 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ethicon |
| Distribution | US |
Product
PDS II SUTURE 18"(45CM) 2-0 VIO Product Code:Z739D - PDS Sutures are intended for use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery. PDS II suture is not indicated in adult cardiovascular tissue, microsurgery and neural tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable
Reason
VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does not match the sales unit carton and foil label.
Identifiers
| code_info | Lot Code: MGM110 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1136-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.