Recall Z-2296-2025— Merit Medical Systems, Inc.
Class II · Ongoing
Class II FDA medical device recall by Merit Medical Systems, Inc., initiated 2025-06-05. FDA's recall record names no specific 510(k) clearance for this event. Product: Custom Waste Management Kit: REF: K10-00353K, K10-01603C, K10-01694Q, K10-05159B, K10-05743, K10-05825AP. Reason: High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the trapped air being introduced into the patient..
- Recalling firm
- Merit Medical Systems, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-06-05
- Firm location
- South Jordan, UT, United States
Product description
Custom Waste Management Kit: REF: K10-00353K, K10-01603C, K10-01694Q, K10-05159B, K10-05743, K10-05825AP
Reason for recall
High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the trapped air being introduced into the patient.
Data sourced from openFDA. This site is unofficial and independent of the FDA.