DePuy Mitek FMS Intermediary Tubing Recalled Due to Valve Malfunction
DePuy Mitek is recalling FMS Intermediary Tubing with One-Way Valve because the pillow valve may not perform as intended, potentially leading to patient cross-contamination.
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 risk of patient cross-contamination, which is a significant health hazard, but no specific injuries or illnesses have been reported in the source text, 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 Co., is recalling the FMS Intermediary Tubing with One-Way Valve (Product Code: 281142). The recall involves 368 packages of the product. The Intermediary Tubing is used in FMS Fluid Management Systems to connect the Inflow Tubing to the arthroscopic sheath during arthroscopic procedures.
The recall is being issued because the pillow valve included in the FMS Duo outflow tubing set and the FMS Solo intermediary tubing set may not perform as intended. This malfunction may result in backflow of irrigation fluid into the One Day Set, which may potentially lead to patient cross-contamination.
The affected products were distributed worldwide, including in the United States and various countries in Europe, Asia, and the Middle East. All lots with a D identifier are included in this recall. Healthcare facilities should stop using the affected products and contact DePuy Mitek for instructions on return or replacement.
The recalled product
- Product
- DePuy Mitek FMS Intermediary Tubing with One-Way valve Product Code: 281142 Product Usage: The Intermediary Tubing for FMS¿ Fluid Management Systems connects the Inflow Tubing to the arthroscopic sheath during arthroscopic procedures. The Polyvinyl Chloride (PVC) tubing…
- Manufacturer
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Category
- Medical Device — Surgical Tubing
- Affected units
- 368
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 (1)
- All lots with a D identifier
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by DePuy Mitek, Inc., a Johnson & Johnson Co. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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