FDA Device recall Z-2147-2024
PDS Plus Antibacterial (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiova…
- FDA Device
- Class II
- ongoing
- Published 2024-06-26
On 2024-06-26 the FDA classified a Class II recall of PDS Plus Antibacterial (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiova… by Ethicon, citing issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2147-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-05-10 |
| Published | 2024-06-26 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ethicon |
| Distribution | US |
Product
PDS Plus Antibacterial (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalmic surgery. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable. PRODUCT CODE: PDP304H PDP316H PDP341H
Reason
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Identifiers
| code_info | GTIN: 10705031047976 10705031048027 10705031048119 PRODUCT CODE PRODUCT LOTS PDP304H TLMJLZ PDP316H UAMKDC PDP341H UBMCZA |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2147-2024%22
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