Recall Z-0073-2025
Merit Medical Systems, Inc. · initiated August 19, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
StabiliT TOUCH Syringe, REF: IN8VCF/B
Codes / lots: REF/UDI-DI/Lot(Expiration): IN8VCF/B/00884450662144/H2918440(5/31/2027), H2938015(7/26/2027).
Reason for recall
Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.
FDA-determined cause: Packaging process control
Action taken
On 8/19/24, recall notices were emailed to customers asking them to do the following: 1) If affected devices are discovered, quarantine them, discontinue use and distribution, and return to the recalling firm. 2) Ensure that applicable personnel within your organization are made aware of this field action. 3) If the product has been further distributed to other facilities, institutions, or manufacturers, please ensure this notice is immediately shared with them and note the quantity distributed on the customer response form. 4) Complete and return the customer response form via email to response@merit.com If you have any questions concerning this communication, please contact the firm's Sales Representatives or Customer Service via email at RESPONSE@merit.com or via phone at +1 800 356 3748, Hours: 6 am to 6 pm MST, Mon-Fri.
Details
- Recall number
- Z-0073-2025
- Initiated
- August 19, 2024
- Posted by FDA
- October 11, 2024
- Product code
- OAR – Injector, Vertebroplasty (Does Not Contain Cement)
- Quantity
- 202
- Distribution
- Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, 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, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of France, Italy, Jamaica, Ireland, Paraguay, Australia, India, Nepal, Japan.
- Recalling firm
- Merit Medical Systems, Inc., South Jordan, UT
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0064-2025 Class II | Blue Diamond Digital Inflation Device, REF: IN7152/C, IN7352/C, IN7403/C, IN7802/C…Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may… | 08/19/2024Open, Classified |
| Z-0065-2025 Class II | basixTOUCH Inflation Device, REF: IN8140/AInflation devices may have a small hole in the sterile barrier of the device and use of affected devices may… | 08/19/2024Open, Classified |
| Z-0066-2025 Class II | DiamondTOUCH Digital Inflation Device, REF: IN9135/A, IN9152/AInflation devices may have a small hole in the sterile barrier of the device and use of affected devices may… | 08/19/2024Open, Classified |
| Z-0067-2025 Class II | IntelliSystem Inflation Device, REF: IN1525/DInflation devices may have a small hole in the sterile barrier of the device and use of affected devices may… | 08/19/2024Open, Classified |
| Z-0068-2025 Class II | BlueFIRE Inflation Device, REF: IN10140Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may… | 08/19/2024Open, Classified |
| Z-0069-2025 Class II | MONARCH Inflation Device, REF: IN2430/B, IN2530/B, IN2130/BInflation devices may have a small hole in the sterile barrier of the device and use of affected devices may… | 08/19/2024Open, Classified |
| Z-0070-2025 Class II | Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K05-00296L…Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may… | 08/19/2024Open, Classified |
| Z-0071-2025 Class II | basixSKY Inflation Device, REF: SKY1802Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may… | 08/19/2024Open, Classified |
| Z-0072-2025 Class II | basixTOUCH Inflation Device, REF: IN8130/JPC, IN8152/C, IN8302/C, IN8352/C, IN8802/C…Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may… | 08/19/2024Open, Classified |