CLASS II Device recall · Reported 7 Mar 2018 · FDA Enforcement Report
1113 Gravity Tube Set Pk/24 -SH recalled by DePuy Mitek, Inc., a Johnson
DePuy Mitek, Inc., a Johnson & Johnson is recalling 1113 Gravity Tube Set Pk/24 -SH, distributed nationwide in the US. The recall was initiated on 31 Aug 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0695-2018
- FDA event ID
- 79117
- Recalling firm
- DePuy Mitek, Inc., a Johnson & Johnson, Raynham, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 31 Aug 2017
- FDA classified
- 23 Feb 2018
- Reported
- 7 Mar 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Surgical Instruments
Timeline
| 31 Aug 2017 | Recall initiated by company | |
| 23 Feb 2018 | Classified by FDA | +176 days |
| 7 Mar 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Leakage of FMS gravity tub sets (281113) at the bulb and tube connection
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide Distribution
Questions about this recall
Why was it recalled?
Leakage of FMS gravity tub sets (281113) at the bulb and tube connection
Which lots are affected?
Lot codes: 138, 194, 633, 1067, 1741, 2576, 2608, and 2645
Where was it sold?
US Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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