Recall Z-2558-2024— Merit Medical Systems, Inc.
Class II · Ongoing
Class II FDA medical device recall by Merit Medical Systems, Inc., initiated 2024-06-11. FDA's recall record names no specific 510(k) clearance for this event. Product: Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Custom Procedure Kit (Angiography/angioplasty kit), REF: K12T-10773 K12T-09284D K12T-10621 K12T-10800 K12T-12491 To support various vascular or cardiac diagnostic and interventional procedures.. Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health..
- Recalling firm
- Merit Medical Systems, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-06-11
- Firm location
- South Jordan, UT, United States
Product description
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Custom Procedure Kit (Angiography/angioplasty kit), REF: K12T-10773 K12T-09284D K12T-10621 K12T-10800 K12T-12491 To support various vascular or cardiac diagnostic and interventional procedures.
Reason for recall
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Data sourced from openFDA. This site is unofficial and independent of the FDA.