DiamondTOUCH Digital Inflation Device, REF: IN9135/A, IN9152/A
Reported: October 23, 2024 Initiated: August 19, 2024 #Z-0066-2025
Product Description
DiamondTOUCH Digital Inflation Device, REF: IN9135/A, IN9152/A
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.
Details
- Recalling Firm
- Merit Medical Systems, Inc.
- Units Affected
- 290
- 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.
- Location
- South Jordan, UT
Frequently Asked Questions
What product was recalled? ▼
DiamondTOUCH Digital Inflation Device, REF: IN9135/A, IN9152/A. Recalled by Merit Medical Systems, Inc.. Units affected: 290.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 23, 2024. Severity: Moderate. Recall number: Z-0066-2025.
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