Merit Medical Systems recalls 368,264 units of the 16F Dual-Valved Splittable Sheath Introducer bulk non-sterile sold worldwide. A design defect may prevent the sheath from splitting as intended, risking hemorrhage and foreign bodies. Healthcare providers should stop using the device and contact Merit Medical for instructions.
16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, and procedure delay.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Merit Medical Systems, Inc. or your healthcare provider for instructions
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Product: 16F Dual-Valved Splittable Sheath Introducer (bulk, non-sterile) REF: FCL-174-00/B. Manufacturer: Merit Medical Systems. Quantity recalled: 368,264 units. Sold worldwide with U.S. distribution to multiple states and international distribution to numerous countries. Recall date: 2026-02-13. Status: ACTIVE. Price: Unknown.
The device design may not split as intended. This can lead to hemorrhage, retained foreign bodies, and procedural delays.
No injuries or incidents have been reported.
1. Stop using the device immediately. 2. Do not attempt to reuse or sterilize. 3. Follow recall instructions provided by Merit Medical or your healthcare provider. 4. Contact Merit Medical Systems for instructions on remedies or replacements.
Manufacturer: Merit Medical Systems, Inc. Website: https://www.merit.com. Phone and hours: Not publicly listed in the recall notice.
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