510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Z-2577-2024Class II

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd...

Merit Medical Systems, Inc. / initiated 2024-06-11 / Open, Classified
FDA source (opens on fda.gov)

Merit Medical Systems, Inc. began a recall of Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: SafeSheath CSG/Worley advanced CSG... on . FDA classified it as Class II and gives the reason as "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". As of , the recall status on record is Open, Classified.

Recall record

Recall number
Z-2577-2024
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Merit Medical Systems, Inc.
Product
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: SafeSheath CSG/Worley advanced CSG (Introducer Catheter kit), REF: FCL-083-02/A WOR-CSG-B1-09/A WOR-CSG-B2-09/A WOR-CSG-BL1-09/A WOR-CSG-E-90/A For the introduction of various types of pacing or defibrillator leads and catheters.
Product code
DYB Introducer, Catheter
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.
FDA root cause
No Marketing Application
Action
On 06/11/2024, the firm sent an "URGENT MEDICAL DEVICE RECALL NOTICE" Letter to customers informing them that specific Merit Medical convenience kits contain plastic syringes manufactured by Jiangsu Shenli Medical Production Co. Ltd. These syringes lack the appropriate/sufficient FDA market authorization. In addition, Merit Medical posted the Urgent Medical Device Recall letter and complete list of affected products/kits on their website at https://www.merit.com/products/documents/product-notices/. Customer are instructed to: 1. Immediately determine if any of the products identified in the attached Customer Response Form (CRF) are within their facility, quarantine them, and discontinue use and distribution. 2. Ensure that appropriate personnel within their organization are made aware of this field action. 3. If the product has been further distributed to other facilities, institutions, or manufacturers, ensure this notice is immediately shared with them. Additional distribution details may be required by health authorities. 4. Follow the attached instructions for placing the recall labels on the products containing Jiangsu Shenli syringes, which inform the users to not use the affected syringes. If additional recall labels are needed, contact Customer Service at (801) 208-4381. Product may be returned to inventory once properly over-labeled. 5.At the point of use, the Jiangsu Shenli syringes are to be discarded. Photographs of Jiangsu Shenli syringes are enclosed to assist in identification. 6.Post this URGENT MEDICAL DEVICE RECALL NOTICE and Jiangsu Shenli Syringe photographs on or near the affected products. 7.If replacement syringes are needed, contact Customer Service at (801) 208-4381 for recommended syringe suppliers. For questions contact Merit Sales Representative or Merit Customer Service at 801-208-4381, Hours: 6 am to 6 pm MST Mon.-Fri.
Quantity in commerce
4027 kits
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.
Product codes and lots
Catalog Number/UDI-DI code/Lot Numbers: FCL-083-02/A 00884450484418 I2808956 I2851068 I2868011 I2931690 WOR-CSG-B1-09/A 00884450484319 I2786685 I2808954 I2818469 I2818470 I2818471 I2828532 I2828533 I2838811 I2851070 I2853922 I2853923 I2868006 I2868008 I2879275 I2889546 I2889548 I2893943 I2901154 I2902413 I2902414 I2912319 I2941927 WOR-CSG-B2-09/A 00884450484456 I2786687 I2818472 I2828534 I2838814 I2853925 I2868009 I2879276 I2889549 I2901183 WOR-CSG-BL1-09/A 00884450484463 I2902412 I2912321 WOR-CSG-E-90/A 00884450484487 I2803269 I2851069 I2931689

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2577-2024
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2557-2024Class IIOngoingVoluntary: Firm initiated
Z-2558-2024Class IIOngoingVoluntary: Firm initiated
Z-2559-2024Class IIOngoingVoluntary: Firm initiated
Z-2560-2024Class IIOngoingVoluntary: Firm initiated
Z-2561-2024Class IIOngoingVoluntary: Firm initiated
Z-2562-2024Class IIOngoingVoluntary: Firm initiated
Z-2563-2024Class IIOngoingVoluntary: Firm initiated
Z-2564-2024Class IIOngoingVoluntary: Firm initiated
Z-2565-2024Class IIOngoingVoluntary: Firm initiated
Z-2566-2024Class IIOngoingVoluntary: Firm initiated
Z-2567-2024Class IIOngoingVoluntary: Firm initiated
Z-2568-2024Class IIOngoingVoluntary: Firm initiated
Z-2569-2024Class IIOngoingVoluntary: Firm initiated
Z-2570-2024Class IIOngoingVoluntary: Firm initiated
Z-2571-2024Class IIOngoingVoluntary: Firm initiated
Z-2572-2024Class IIOngoingVoluntary: Firm initiated
Z-2573-2024Class IIOngoingVoluntary: Firm initiated
Z-2574-2024Class IIOngoingVoluntary: Firm initiated
Z-2575-2024Class IIOngoingVoluntary: Firm initiated
Z-2576-2024Class IIOngoingVoluntary: Firm initiated
Z-2577-2024Class IIOngoingVoluntary: Firm initiated
Z-2578-2024Class IIOngoingVoluntary: Firm initiated
Z-2579-2024Class IIOngoingVoluntary: Firm initiated