Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K05-00296L, K05-00399D, K05-00404C, K05-00410G, K05-00438G, K05-00502F, K05-00564L, K05-00587D, K05-00612Q, K05-00704F, K05-00724F, K05-00793B, K05-00798, K05-00890D, K05-00890D, K05-00944D, K05-00956D, K05-01018C, K05-01051, K05-01104G, K05-01140D, K05-01194G, K05-01274D, K05-01304A, K05-01756B, K05-01820B, K05-01853A, K05-01855L, K05-01895A, K05-01933A, K05-02161, K05-02431A, K05-02487A, K05-02489C, K05-02495B, K05-02554, K05-02573, K05-02575, K05-02595, K05-02595, K05-02657A, K05-02810, K05-02887, K05-03069A, K05-03095B, K05-03112, K05-03124, K05-03150, K05-50037G
Enforcement
- Recall Number
- Z-0070-2025
- Event ID
- 95343
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Merit Medical Systems, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 23, 2024
- Initiation Date
- August 19, 2024
- Classification Date
- October 11, 2024
- Address
- 1600 W Merit Pkwy, South Jordan, UT, 84095-2416, United States
Description
Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K05-00296L, K05-00399D, K05-00404C, K05-00410G, K05-00438G, K05-00502F, K05-00564L, K05-00587D, K05-00612Q, K05-00704F, K05-00724F, K05-00793B, K05-00798, K05-00890D, K05-00890D, K05-00944D, K05-00956D, K05-01018C, K05-01051, K05-01104G, K05-01140D, K05-01194G, K05-01274D, K05-01304A, K05-01756B, K05-01820B, K05-01853A, K05-01855L, K05-01895A, K05-01933A, K05-02161, K05-02431A, K05-02487A, K05-02489C, K05-02495B, K05-02554, K05-02573, K05-02575, K05-02595, K05-02595, K05-02657A, K05-02810, K05-02887, K05-03069A, K05-03095B, K05-03112, K05-03124, K05-03150, K05-50037G
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.
REF/UDI-DI/Lot(Expiration): K05-00052M/00884450138120/H2934735(5/5/2027), H2943603(5/19/2027). K05-00053H/00884450052921/H2918538(4/22/2027), H2934736(5/5/2027). K05-00109G/00884450464533/H2918443(4/15/2027), H2925236(4/22/2027), H2943604(5/19/2027). K05-00137K/00884450290316/H2925237(12/31/2026), H2934737(5/12/2027). K05-00296L/00884450467824/H2918499(4/29/2027), H2925271(4/29/2027). K05-00399D/00884450138298/H2929510(4/29/2027), H2934739(5/12/2027). K05-00404C/00884450138304/H2918500(4/29/2027). K05-00410G/00884450142295/H2918501(4/15/2027), H2934833(5/12/2027). K05-00438G/00884450142301/H2918502(4/15/2027), H2934834(5/5/2027), H2978145(6/3/2027). K05-00502F/00884450138427/H2918505(4/15/2027), H2934837(5/5/2027). K05-00564L/00884450257166/H2934839(5/5/2027). K05-00587D/00884450052952/H2918446(4/22/2027), H2934744(5/5/2027), H2938620(5/12/2027). K05-00612Q/00884450138519/H2925240(4/22/2027), H2934746(5/5/2027), H2943608(5/26/2027). K05-00704F/00884450138588/H2918508(4/15/2027), H2938622(5/12/2027). K05-00724F/00884450146538/H2918509(4/15/2027). K05-00793B/00884450236987/H2918448(4/15/2027), H2929514(4/29/2027), H2938623(5/12/2027). K05-00798/00884450046951/H2925242(4/22/2027), H2943609(5/19/2027). K05-00890D/00884450453629/H2918449(4/15/2027), H2929515(4/29/2027). K05-00890D/00884450453629/H2934749(5/5/2027), H2943610(5/19/2027). K05-00944D/00884450151631/H2918450(4/15/2027), H2929516(4/29/2027). K05-00956D/00884450142448/H2918511(4/15/2027), H2925278(4/22/2027), H2938625(5/12/2027). K05-01018C/00884450152324/H2925244(4/22/2027), H2938626(5/12/2027). K05-01051/00884450047057/H2925280(4/22/2027). K05-01104G/00884450145401/H2925285(4/22/2027), H2929540(4/29/2027), H2934846(5/5/2027). K05-01140D/00884450147931/H2925286(4/22/2027), H2934847(5/5/2027), H2972616(5/26/2027). K05-01194G/00884450409091/H2925288(4/22/2027). K05-01274D/00884450160596/H2918453(4/22/2027), H2934750(5/12/2027), H2938628(5/12/2027). K05-01304A/00884450279014/H2972617(5/26/2027). K05-01756B/00884450145449/H2929520(4/29/2027). K05-01820B/00884450639115/H2929521(4/29/2027), H2943614(5/19/2027). K05-01853A/00884450153864/H2918460(4/15/2027), H2934761(5/12/2027), H2943615(5/19/2027). K05-01855L/00884450453667/H2918518(4/15/2027), H2978189(6/3/2027). K05-01895A/00884450141458/H2929522(5/26/2027). K05-01933A/00884450462768/H2918519(4/15/2027), H2934855(5/5/2027). K05-02161/00884450139738/H2918522(4/15/2027), H2925298(4/29/2027), H2943617(5/19/2027), H2978192(6/3/2027). K05-02431A/00884450150191/H2929525(4/29/2027). K05-02487A/00884450140468/H2918472(4/15/2027). K05-02489C/00884450639177/H2938638(5/12/2027). K05-02495B/00884450257326/H2925259(4/22/2027), H2934775(5/5/2027). K05-02554/00884450148372/H2934780(5/5/2027). K05-02573/00884450148884/H2918476(4/15/2027). K05-02575/00884450158500/H2938639(5/12/2027). K05-02595/00884450165881/H2918525(4/15/2027), H2929547(4/29/2027), H2938640(5/12/2027). K05-02595/00884450165881/H2972630(5/26/2027), H2982566(6/10/2027). K05-02657A/00884450639214/H2918480(4/15/2027), H2925265(4/29/2027), H2934784(5/5/2027), H2938643(5/12/2027), H2982568(6/10/2027). K05-02810/00884450253083/H2929528(4/29/2027), H2938646(5/12/2027). K05-02887/00884450285923/H2918527(4/29/2027), H2925313(4/29/2027), H2934862(5/12/2027). K05-03069A/00884450461440/H2938301(3/31/2027). K05-03095B/00884450639429/H2925319(4/22/2027), H2938649(5/12/2027). K05-03112/00884450404492/H2938650(5/12/2027). K05-03124/00884450432631/H2934820(5/5/2027), H2938651(5/12/2027), H2978212(6/3/2027). K05-03150/00884450480045/H2925320(4/22/2027). K05-50037G/0088445045609/H2925266(4/29/2027), H2934824(5/5/2027), H2938652(5/12/2027).
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.
7,099