Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K02
Summary
The FDA issued a Class II for Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medi by Merit Medical Systems, Inc.. Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issue.
Details
Source
Device Recall
External ID
Z-2560-2024
Action Date
2024-08-21
Status
Ongoing
Category
device
Product Description
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K02 (Custom Syringe Kit), REF: K02-00873A, Inject fluids into, or withdraw fluids from, the body.
Lot/Code Info: Catalog Number: K02-00873A UDI-DI code: 00884450156261 Lot Numbers: H2597212 H2620955 H2641148 Catalog Number: K02-01105A UDI-DI code: 00884450156124 H2486384 H2542259 H2628908 Catalog Number: K02-01481A UDI-DI code: 00884450164464 H2387157 H2418377 H2472043 H2486729 H2507912 H2517550 H2526240 H2552843 H2595093 H2628968 H2655130 H2678790 H2699921 H2712471 H2747868 H2822453 H2831126 H2846806 H2868403 H2884580 H2897149 H2916452
Quantity Affected: 3,647 kits
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-06-11
Company
South Jordan, UT
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 202 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Merit Medical Systems, Inc. has 117 FDA actions in our database, including 95 recalls and 22 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Merit Medical Systems, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Merit Medical Systems, Inc. have FDA actions?
Merit Medical Systems, Inc. has 117 FDA actions in our database, including 95 recalls and 22 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2560-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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