Various Merit Medical convenience kits that contain recall
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K08-PI (Custom Fluid Management…
Why was Various Merit Medical convenience kits that contain recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog Number: K08-02042 UDI-DI code: 00884450179994 Lot Numbers: H2791360 H2825591 H2832445 H2855331 H2874529 H2897347 Catalog Number: K08-02948 UDI-DI code: 00884450250846 Lot Numbers: H2409549 H2421264 H2454187 H2471302 H2555399 H2560081 H2590001 H2608380 H2616367 H2641745 H2689450 H2718414 H2778302 H2824898 H2835712 H2849743 H2866799 H2875231 H2880035 Catalog Number: K08-03026 UDI-DI code: 00884450280416 Lot Numbers: H2414033 H2437895 H2474035 H2489683 H2518365 H2583262 H2584710 H2596210 H2836476 H2864917 H2881380 H2906069 H2912967 Catalog Number: K08-03119 UDI-DI code: 00884450333716 Lot Numbers: H2424087 H2465222 H2500943 H2519412 H2519413 H2708309 H2744000 H2806045 H2837641 H2846068 H2865870 H2872906 H2879960 H2912192
- Product
- Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K08-PI (Custom Fluid Management…
- Recalling firm
- Merit Medical Systems, Inc.
- Quantity
- 3,694 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.
- Recall date
- August 21, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)