Z-0695-2018Class II

1113 Gravity Tube Set Pk/24 -SH

Name: Z-0695-2018 1113 Gravity Tube Set Pk/24 -SH
Creator: DePuy Mitek, Inc., a Johnson & Johnson Co.
Published: 2017-08-31
License: https://open.fda.gov/license/

DePuy Mitek, Inc. / initiated 2017-08-31 / Terminated / root cause: manufacturing process

FDA source

DePuy Mitek, Inc., a Johnson & Johnson Co. began a 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 to the operative... on 2017-08-31. FDA classified it as Class II and gives the reason as "Leakage of FMS gravity tub sets (281113) at the bulb and tube connection". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0695-2018
Classification: Class II
Status: Terminated
Initiated: 2017-08-31
Posted: 2018-02-23
Terminated: 2019-04-09
Recalling firm: DePuy Mitek, Inc.
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.
Product code: JCY Catheter, Infusion
Reason for recall: Leakage of FMS gravity tub sets (281113) at the bulb and tube connection
Root cause tag: manufacturing process
FDA 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 in commerce: 15,678
Distribution: US Nationwide Distribution
Product codes and lots: Lot codes: 138, 194, 633, 1067, 1741, 2576, 2608, and 2645

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0695-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0695-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-23

Product code JCY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)