Reported Mar 7, 2018 · Terminated

1113 Gravity Tube Set Pk/24 -SH Product Usage: The FMS Gravity Tube Set is intended to deliver irrigation fluid from…

DePuy Mitek, Inc., a Johnson & Johnson Co.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: DePuy Mitek, Inc., a Johnson & Johnson Co. · 325 Paramount Dr · Raynham, MA · 02767-5199

Is this the product you have?

  • 1113 Gravity
  • Tube Set Pk/24 -SH Product UsageThe FMS Gravity Tube Set is intended to deliver irrigation fluid from irrigation containers to the operative site during arthroscopic procedures
Lot codes and dates
  • Lot codes
    • 138
    • 194
    • 633
    • 1067
    • 1741
    • 2576
    • 2608
    • and 2645
Amount recalled
15,678

Where it was sold

  • Nationwide

Why it was recalled

Leakage of FMS gravity tub sets (281113) at the bulb and tube connection

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 9, 2019 · Data as of Sep 19, 4:45 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.