Z-2566-2024Class 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
Merit Medical Systems, Inc. began a recall of Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K11 (Custom Pressure Monitoring Kit), REF... 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-2566-2024
- 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: K11 (Custom Pressure Monitoring Kit), REF: K11-00382C To support fluid administration into the body and physiological pressure monitoring. To support various vascular or cardiac diagnostic and interventional procedures.
- Product code
- OEZ Cardiovascular Procedure Kit
- 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
- 69 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: K11-00382C 00884450158425 H2379628 H2531736 H2536619 H2813488 H2881603 H2916468
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2557-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2558-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2559-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2560-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2561-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2562-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2563-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2564-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2565-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2566-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2567-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2568-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2569-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2570-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2571-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2572-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2573-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2574-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2575-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2576-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2577-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2578-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2579-2024 | Class II | Ongoing | Voluntary: Firm initiated |
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