FDA Device recall Z-1617-2018
Capio SLIM Box 5, Model #M0068318261
- FDA Device
- Class II
- terminated
- Published 2018-05-16
On 2018-05-16 the FDA classified a Class II recall of Capio SLIM Box 5, Model #M0068318261 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-1617-2018 |
| 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 Box 5, Model #M0068318261; 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: 19083076 19490462 20703048 19138102 19575737 20703101 19138104 19579790 2070638…UDI:08714729842224. Batch numbers: 19083076 19490462 20703048 19138102 19575737 20703101 19138104 19579790 20706387 20552143 19583816 20779052 20552145 19588973 20786955 20552147 19604718 20838609 20552300 19715051 20838611 19138106 19720437 20838613 19138108 19730190 20838615 19334997 19760389 20838617 20552153 19818985 20838619 17685429 19825371 20838661 17689642 19868166 20838663 17774102 19868170 20838665 17777555 19873851 20838667 17792395 19873853 20838670 17899922 19945906 20902946 17906429 19950376 20908772 17907124 19965002 20908774 17907855 19998515 20908776 17915689 20000798 20908778 17919851 20001166 20923178 17920787 20005049 20933960 17985873 20061149 20933962 17990901 20061151 20968696 17995421 20061153 20971515 17997519 20061155 20978294 18001945 20078729 21058901 18005330 20079183 21135392 18024683 20179283 21149060 18036357 20179505 21153916 18104991 20183190 21153918 18111726 20183193 21238940 18115409 20189154 21240810 18120488 2 |
|---|
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-1617-2018%22
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