FDA Device recall Z-0695-2018
1113 Gravity Tube Set Pk/24 -SH Product Usage: The FMS Gravity Tube Set is intended to deliver irrigation fluid from irrigation containers…
- FDA Device
- Class II
- terminated
- Published 2018-03-07
On 2018-03-07 the FDA classified a Class II recall of 1113 Gravity Tube Set Pk/24 -SH Product Usage: The FMS Gravity Tube Set is intended to deliver irrigation fluid from irrigation containers… by Depuy Mitek A Johnson And Johnson, citing leakage of FMS gravity tub sets (281113) at the bulb and tube connection.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0695-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-08-31 |
| Published | 2018-03-07 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Depuy Mitek A Johnson And Johnson |
| Distribution | US |
Product
1113 Gravity Tube Set Pk/24 -SH Product Usage: The FMS Gravity Tube Set is intended to deliver irrigation fluid from irrigation containers to the operative site during arthroscopic procedures.
Reason
Leakage of FMS gravity tub sets (281113) at the bulb and tube connection
Identifiers
| code_info | Lot codes: 138, 194, 633, 1067, 1741, 2576, 2608, and 2645 |
|---|
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-0695-2018%22
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