FDA Device recall Z-1621-2018
Capio RP
- FDA Device
- Class II
- terminated
- Published 2018-05-16
On 2018-05-16 the FDA classified a Class II recall of Capio RP by Boston Scientific, citing potential for Capio sutures to break and /or detach.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1621-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-02-12 |
| Published | 2018-05-16 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Boston Scientific |
| Distribution | GA |
Product
Capio RP; Model #M0068321010. Intended for use in general suturing applications during open surgery to assist in the placement of suture material in tissues at the operative site.
Reason
Potential for Capio sutures to break and /or detach.
Identifiers
| code_info | UDI:08714729470212 Batch numbers: 17813516 18653139 19987270 18014753 18886132 20278129 18015797 19173287 20604455…UDI:08714729470212 Batch numbers: 17813516 18653139 19987270 18014753 18886132 20278129 18015797 19173287 20604455 18015964 19335466 20844362 18234939 19491590 21178815 18237323 19693866 21227473 21386746 |
|---|
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-1621-2018%22
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