Merit Medical Systems, Inc.: Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Prelude SNAP-H (Introducer Catheter kit), REF: PLSH-1006/

Hazard

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.

Details from the source

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. Distribution: 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. Quantity: 745 kits Lot/code info: 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

UPC codes

00884450495049, 00884450495056, 00884450495087, 00884450495568, 00884450495490, 00884450495506

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.