DePuy Mitek FMS Outflow Tubing Recalled Due to Valve Malfunction
DePuy Mitek is recalling FMS Outflow Tubing because the pillow valve may not perform as intended, potentially leading to backflow of irrigation fluid and 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-harm product (potential patient cross-contamination) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
DePuy Mitek, Inc., a Johnson & Johnson Co., is recalling the FMS Outflow Tubing with One-Way valve (Product Code 284649). The recall involves 29,280 units distributed worldwide, including the United States and 22 other countries. The product is intended for single use in arthroscopic procedures to connect inflow tubing to the arthroscopic sheath.
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.
Healthcare facilities and distributors should stop using the affected tubing and contact DePuy Mitek for instructions on return or replacement. The recall covers all lot codes for the specified product.
The recalled product
- Product
- DePuy Mitek FMS Outflow Tubing with One-Way valve Product Code:284649 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
- 29,280
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 lot codes
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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