Merit Medical Systems, Inc.: Medical Device Recall in 2024 - (Recall #: Z-2575-2024)
See the recall detail below. You can also see other recalls from the same firm in 2024.
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Prelude SNAP-H (Introducer Catheter kit), REF: PLSH-1006/A PLSH-1007/A PLSH-1008/A PLSH-1009.5/A PLSH-2506/A PLSH-2507/A For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.
Class II
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.
Catalog Number/UDI-DI code/Lot Numbers: PLSH-1006/A 00884450495049 I2868424 PLSH-1007/A 00884450495056 I2889342 I2903951 PLSH-1008/A 00884450495087 I2873505 PLSH-1009.5/A 00884450495568 I2873507 PLSH-2506/A 00884450495490 I2872319 I2914441 PLSH-2507/A 00884450495506 I2868427 I2889346
U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.
Voluntary: Firm initiated