Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956 K12T-10922B
USMerit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956 K12T-10922B
Recalling Firm: Merit Medical Systems, Inc.
Motivo del Retiro / Peligro
TranslatedInflation device handle may detach from the syringe during procedure.
Descripción del Producto e Identificación
TranslatedMerit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956 K12T-10922B
Productos Afectados
TranslatedMerit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956 K12T-10922B
Additional Source Details
| Field | Value |
|---|---|
| City | South Jordan |
| State | UT |
| Event id | 98139 |
| Address 1 | 1600 W Merit Pkwy |
| Code info | Reference Number/UDI Number/Lot Number(s) K12T-04270A: UDI: 00884450389683/ Lot: T2643938 T2728112 T2783917 T2806210 T2811252 K12T-07956: UDI: 00884450264003/ Lot: K2618155 K2618156 K12T-10922B: UDI: 00884450481660/Lot: T2851185 T2876341 T2990792 T3063197 T3070788 T3165727 T3223759 T3312055 |
| Postal code | 84095-2416 |
| Report date | 20260128 |
| Product type | Devices |
| Reason for recall | Inflation device handle may detach from the syringe during procedure. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251204 |
| Initial firm notification | |
| Center classification date | 20260116 |
Consumer Action Protocol: What You Should Do Immediately
Safety StepsInspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.
Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.
Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.
If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (FDA Devices).
Your Legal Rights as a Consumer
Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.
Frequently Asked Questions About This Recall
FAQ GuideQ1:What should I do immediately if I own or bought Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956 K12T-10922B?
Check the lot number and NDC on your prescription label. For essential medications, consult your doctor or dispensing pharmacist immediately before abruptly stopping your dose.
Q2:Can I get a full refund or free repair for this recall?
Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.
Q3:Do I need my original sales receipt to claim a remedy or refund?
In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.
Q4:Where can I verify official information for this safety alert?
This safety alert is aggregated directly from official regulatory agency records (FDA Devices). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.
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Resumen
- Empresa ResponsableMerit Medical Systems, Inc.
- StatusOngoing
- Nivel de RiesgoClass II
- DistributionWorldwide - 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, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY, St. Thomas , Puerto Rico and the countries of Albania, Algeria, Angola, Argentina, Australia, Austria, Bahrain, Barbados, Belgium, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Iceland, India, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Kazakhstan, Korea, Republic of Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Luxembourg, Madagascar, Mexico, Monaco, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Poland, Portugal, Qatar, Romania, Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Trinidad and Tobago, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Bolivarian, Republic of Viet Nam.
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🚨 SAFETY ALERT: Merit Medical Systems, Inc. - Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956 K12T-10922B Check if your household is affected: https://therecallfile.com/es/recalls/merit-medical-custom-procedure-kit-reference-numbers-k12t-04270a-k12t/FDA-Z-1128-2026
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