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Recall Observatory FDA recall evidence

Device product

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: ReSolve (Catheter and Tip Suction kit), REF: RTT14038MB/A The ReSolve Thoracostomy Tray is indicated for the percutaneous removal of air and fluid from the pleural space.

Z-2570-2024

June 11, 2024

Class II

Product summary

Firm
Merit Medical Systems, Inc.
Event
Event 94797
Status
Ongoing
Classification
Class II
Quantity
7442 kits
Official record key
device-enforcement:Z-2570-2024

Official wording

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.

Code information: Catalog Number/UDI-DI code/Lot Numbers: RTT14038MB/A 00884450680100 T2882458 T2775532 T2692992 T2745797 T2823440 T2758669 T2882467 T2855297 T2692990 T2864420 T2762237 T2701080 T2748465 T2872143 T2853478 T2865442 T2560919 T2607047 T2617261 T2933737 T2657108 T2886240

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.