FDA Medical Device Recalls (openFDA)
DePuy Mitek, Inc., a Johnson & Johnson Co.: 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.
- Recall number
- Z-0695-2018
- Recalling firm
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- 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.
- Status
- Terminated
- Initiated
- 2017-08-31
- Posted
- not on file
- Terminated
- 2019-04-09
- Reason
- Leakage of FMS gravity tub sets (281113) at the bulb and tube connection
- Root cause
- Nonconforming Material/Component
- Action
- On September 6, 2017 an URGENT MEDICAL DEVICE RECALL letter was issued to customers titled "FMS Gravity Tubing" requesting that customers cease further distribution or use, quarantine all remaining products and contact sales consultant for the coordination of return and replacement. Questions or concerns can be directed to the recall coordinator at 508-828-6609
- Quantity
- 15,678
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- Lot codes: 138, 194, 633, 1067, 1741, 2576, 2608, and 2645
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JCY
- Firm FEI
- 1221934
- Firm city
- Raynham
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28