Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Saf
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-2577-2024
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: 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.
Lot/Code Info: 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
Quantity Affected: 4027 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-2577-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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