FDA Device recall Z-1616-2018
Capio SLIM Suture Capturing Device, Model #M0068318250
- FDA Device
- Class II
- terminated
- Published 2018-05-16
On 2018-05-16 the FDA classified a Class II recall of Capio SLIM Suture Capturing Device, Model #M0068318250 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-1616-2018 |
| 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 SLIM Suture Capturing Device, Model #M0068318250. 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:08714729842224. Batch numbers: 17781206 19335463 20312941 17782808 19435078 20423794 17790316 19568158 2045371…UDI:08714729842224. Batch numbers: 17781206 19335463 20312941 17782808 19435078 20423794 17790316 19568158 20453711 17792469 19573475 20453712 17986321 19701151 20475301 17991696 19711511 20484084 18106407 19833973 20484085 18110253 19858683 20532136 18213570 19858950 20628943 18304052 19882066 20633409 18384108 19882067 20637817 18407974 19887279 20693087 18420687 19942844 20697608 18492494 19959781 20838671 18494737 19963492 20838674 18620481 19993297 20838675 18740238 20000796 20838676 18792184 20001160 20902944 18855259 20001161 20968694 18922488 20006757 21065530 18925301 20009446 21135395 19027722 20017944 21166978 19138109 20202691 21168424 19173080 20203473 21168425 19243603 20305797 21258657 19243604 20305799 21362103 19335462 20305920 21386335 |
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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-1616-2018%22
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