FDAFDA · Food and drugs·Recall number Z-2642-2024
Vial Decanter, REF 2006S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
Published August 28, 2024 · Recall initiated: June 3, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Microtek Medical Inc.
- Distributor
- Distributed nationwide and internationally to Canada, Mexico, New Zealand, Belize, and Hong Kong.
- Lot
- SKU/UDI-Device Identifier: 2006S/00748426002511; Lot Numbers: 191216,191122,211019,210916,210604,210313,201017,181211,181212,191211,190627,190812,190617,200506,190531,190618,190808,210503,190609,190808,191216,190609,190722,190307,191015,190513,190524,190703,190808,190807,190531,200402,190326,221029,220920,220914,220427,220404,220420,230612,230607,231028,230320,230320,221207,221027,221027,221008,220926,220920,220914,220909,220515,211111,220322,220408,211117,210708,211023,210523,210313,210523,210308,210114,201017,191216,191026,190925,190513,190808,181212,190808,191216,201008,190530,191107,190910,200505,191119,200320,181108,191216,181108,181212,190423,200618,190531,190927,191218,190627,190423,190531,200804,200218,190627,190424,200507,191011,211113,211103,211023,210910,210909,210708,210605,210413,210412,210412,210412,210319,210126,210114,210218,210107,201010,201006,201006,200605,181126,190722,191024,191024,191205,191011,200819,190609,190609,181212,191024,190910,200106,191024,190905,191120,181121,190926,191227,190513,200324,190531,200504,190812,190424,181023,231204,231204,231107,231107,231014,230707,230707,230515,230413,230328,221221,221216,221029,221028,221020,221018,221008,220928,221122,220923,220924,220922,220914,220505,220515,220504,200820,200602,200414,190609,200804,191216,190311,200905,181121,181112,181108,181203,200318,190104,191216,200605,190424,200226,190812,181212,191122,191107,200824,191205,190530,200605,191122,191122,191120,190910,200320,200210,190311,200605,181211,181203,200824,200403,200226,191205,190326,190531,211009,211110,210708,211113,211113,211110,211110,211103,210311,210604,210708,211113,211020,210915,210803,210915,211020,210911,210803,210712,210503,210712,211010,210916,210803,211010,210916,210910,210909,210722,210722,210713,210707,210708,210605,210605,210604,210523,210604,210603,210523,210523,210523,210510,210524,210524,210503,210524,210503,210413,210412,210319,210410,210410,210319,210319,210410,210412,210410,2103067,210313,210312,210311,210308,210306,210129,210126,210115,210114,210219,210218,210218,210106,201021,201017,201021,210107,210107,210105,201017,201017,210112,201010,201006,201006,201008,200618,200505,200414,190722,181212,181212,200602,200318,190530,190513,200320,190910,181108,181108,200226,190423,200403,181121,200820,200228,190417,200504,200703,190722,190722,181203,181203,181206,181206,181206,190530,190513,191028,191205,200403,200318,190807,181108,200324,190530,200113,200228,200226,191218,190305,181112,190326,200504,190627,181203,200819,200403,191216,191026,200106,221215,221207,221122,221018,221020,221017,220928,220926,220404,220514,220928,220426,220404,220322,211209,220122,220409,211209,211208,220322,220322,210708,211023,210712,210712,220411,220411,231107,231028,230607,221222,221222,221216,221216,221028,221018,221018,221008,220928,220923,220408,211111,181108,210112,210112,231204,231005,230707,200228,200602,181121,200414,190104,190925,200218,191119,191205,191014,200824,190423,200507,190808,181212,191107,200605,210115,210112,190530,190311,200403,191105,200228,191205,191120,190513,190609,190927,190703,200310,200425,200402,200804,190326,231116,231114,230707,220914,220412,220428,191014,191014,200320,200403,191216,200605,200403,200210,200820,181112,210308,200218,200804,200506,200414,191107,210114,210105,210105,201017,201017,201008,191119,191205,200324,200403,191227,191011,191011,190910,200228,191028,200226,200504,200324,200113,200113,210413,210107,201012,201006,201006,200425,200820,200819,231028,190423,190424,190326,190513,190424,190417,190311,190417,181206,181206,190513,190401,181206,190401,190812,190722,190609,190722,190807,220909,211209,190618,190424,190311,190305,191122,191205,191026,191026,191026,190925,200320,200228,181112,200414,200226,200425,200218,190307,190307,181203,190104,181206,190530,211019,211020,211020,211009,210803,210911,210712,210712,210712,210707,210712,211019,211010,201012,210114,210523,210603,210312,210410,210410,210315,210312,210126,210129,201021,210108,210107,201017,201006,200824,200
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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