DePuy Mitek Recalls FMS Gravity Tube Sets Due to Leakage
DePuy Mitek is recalling FMS Gravity Tube Sets because they may leak at the bulb and tube connection during arthroscopic procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device defect (leakage) that poses a risk of harm during surgical procedures, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
DePuy Mitek, Inc., a Johnson & Johnson company, is recalling 15,678 units of the 1113 Gravity Tube Set (Pk/24 -SH). The product is intended to deliver irrigation fluid from containers to the operative site during arthroscopic procedures.
The recall is due to leakage at the bulb and tube connection. The affected units were distributed nationwide in the United States. Specific lot codes involved in the recall are 138, 194, 633, 1067, 1741, 2576, 2608, and 2645.
Healthcare facilities and consumers should stop using the affected products and contact DePuy Mitek for instructions on return or replacement.
The recalled product
- 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.
- Manufacturer
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Affected units
- 15,678
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Lot codes: 138
- 194
- 633
- 1067
- 1741
- 2576
- 2608
- and 2645
Distribution
Distributed nationwide across the United States.
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