AccessPLUS Large Bore Hemostasis Valves, Catalog Code: 580758001, 580774001, IN8152/C, K04-01197, K05T-01863, K09-09102B
Summary
The FDA issued a Class II for AccessPLUS Large Bore Hemostasis Valves, Catalog Code: 580758001, 580774001, IN8 by Merit Medical Systems, Inc.. Reason: A design change made to a hemostasis valve to improve manufacturability caused an internal gap between the rotator and the Y-body, where the guidewire.
Details
Source
Device Recall
External ID
Z-0904-2022
Action Date
2022-04-20
Status
Ongoing
Category
device
Product Description
AccessPLUS Large Bore Hemostasis Valves, Catalog Code: 580758001, 580774001, IN8152/C, K04-01197, K05T-01863, K09-09102B, K09-10388A, K09-12917, K09-13501AP, K10-05457AP, K10-05635, K10-05868P, K10-05872P, K12-08303, K12-10346, K12-10375, K12-10724AP, K12-10962, K12-11413, MAP150/F, MAP152/B, MAP152/F, K12-01551, K12-YP064A, K12-YP114, K12-YP115, K12-YS047A, IN8152, K12-01551
Lot/Code Info: Catalog Code/Lots: 580758001/P2073001; 580774001/I2219768; IN8152/C/H2292361, H2287442, H2281419, H2287443, H2298629, H2298630, H2305054, H2281405, H2305053, H2309362; K04-01197/H2296388; K05T-01863/T2313699; K09-09102B/H2308279; K09-10388A/H2285501; K09-12917/H2288582; K09-13501AP/H2265140; K10-05457AP/H2248304, H2265127, H2311255; K10-05635/H2285675, H2309893, H2305137; K10-05868P/H2278583; K10-05872P/H2275807, H2283595, H2309793, H2319811; K12-08303/H2266358, H2271477, H2295915 K12-10346/H2275972; K12-10375/H2290010; K12-10724AP/H2275826, H2299830; K12-10962/H2290113; K12-11413/H2262277, H2272368; MAP150/F/I2279928, I2259668; MAP152/B/P1908669, P1908670; MAP152/F/I2215502, I2259669, I2279933, I2289615, I2176727, I2289614, I2289616, I2279930; K12-01551/H2269831; K12-YP064A/H2288338, H2302500; K12-YP114/H2258787, H2288909, H2302503; K12-YP115/H2288352, H2302505; K12-YS047A/H2290278; IN8152/H2305053, H2305054, H2309362; K12-01551/H2269831
Quantity Affected: 58963
Reason for Recall
A design change made to a hemostasis valve to improve manufacturability caused an internal gap between the rotator and the Y-body, where the guidewire can get caught, resulting in difficulty advancing the guidewire through the device. This defect may result in a delay of procedure.
Distribution
US: MN, PA, AZ, FL, IL, AK, NY, CA, TX, KY, WI, NC, NJ, VA, CO, IN, AR, MO, LA, OR, MT, MA, MI, NE, WV, KS, MS, HI, IA, NH, ME, AL, DC, DE, NM, OH, GA, MD, TN, UT, RI, SC, OK, WA, ID, ND, SD, NV, VT. OUS: Poland, Germany, France, United Kingdom, Belgium, Korea, Republic of, Austria, Canada, Spain, Luxembourg, Italy, Switzerland, Czech Republic, Netherlands, Japan, Honduras, Colombia, Greece, Ireland
Type: Voluntary: Firm initiated
Recall Initiated: 2022-03-01
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 137 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-0904-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29