—#210078

Product

basixSKY Inflation Device, REF: SKY1802

FDA product code: PTM — Syringe, Balloon Inflation, Exempt
Device class: Class 2
Medical specialty: Cardiovascular
Affected lot / code info: REF/UDI-DI/Lot(Expiration): SKY1802/00884450822500/H2925228(11/30/2026), H2934728(11/30/2026).

Why it was 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.

Root cause (FDA determination)

Packaging process control

Action the firm took

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.

Recalling firm

Firm: Merit Medical Systems, Inc.
Address: 1600 W Merit Pkwy South, Jordan, Utah 84095-2416

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2024-08-19
Posted by FDA: 2024-10-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #210078. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.