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FDAFDA · Food and drugs·Recall number Z-2640-2024

Bag Decanter II, REF 2002S. 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: 2002S/00748426002399; Lot Numbers: 200403,211013,210626,200409,190913,200420,200422,200422,190510,190319,200108,190415,190702,190109,190827,191022,200313,200306,200312,191212,190226,190802,181113,181221,191213,191019,200617,181130,190114,200313,190620,191228,211109,211109,211107,211109,211021,211022,211012,211012,211026,211018,211105,211105,211105,211012,211007,210913,210913,210908,210802,210806,210810,210903,210902,210902,210812,210809,210718,210709,210729,210810,210328,210823,210729,210802,210802,210719,210728,210703,210625,210622,210704,210618,210618,210710,210610,210520,210519,210408,210518,210518,210518,210517,210512,210520,210318,210502,210502,210318,210317,210422,210409,210405,210403,210404,210329,210422,210327,210404,210325,210323,210402,210304,210220,210127,210121,210117,201208,201204,201204,201013,201127,201126,201102,201028,201022,201026,200906,200912,200904,200616,201007,190218,190729,190916,200513,200329,190426,181218,181221,200417,200514,200513,190823,190823,191021,190306,181124,191112,191213,191112,190108,190327,191127,190121,191004,191004,190725,200512,190419,200615,200611,190306,190506,191018,190227,190528,181107,190102,200102,181129,190716,190716,190116,181220,181225,181225,181214,190725,210618,181107,231129,200107,210618,181011,181214,181225,200421,190724,191212,200728,190802,190805,200422,191218,190912,191017,191112,200422,200403,190624,200221,190109,191019,190307,190802,181113,190409,190402,200227,190912,190402,181221,191212,190218,191111,190321,200811,190306,190114,191212,200103,200403,200511,190628,191228,200320,191212,211204,211021,211105,211011,211012,211108,211026,211026,211017,211017,211014,211013,211007,210913,210926,211007,210907,210902,210812,210826,210718,210806,210709,210726,210823,210729,210811,210802,210721,210728,210721,210703,210802,210704,210710,210704,210619,210618,210618,210610,210613,210408,210408,210613,210518,210517,210507,210509,210509,210317,210317,210409,210327,210326,210323,210323,210303,200421,210220,210121,210111,201126,201203,201204,201127,201126,201113,201113,201027,201028,201014,201014,201026,200929,200910,200928,200928,200928,200907,190322,191114,191112,191018,191018,190415,191111,191012,200728,200305,181128,181217,181213,200326,200417,190425,200513,191127,191111,190823,190215,190108,200912,190619,200417,191112,190725,181124,181109,191023,190916,190723,200320,181219,190318,190422,190422,191125,200302,190118,190813,190225,190320,200421,190520,181129,190915,190322,190704,200415,181106,190704,190416,190415,200108,200304,200320,200518,190226,191226,230711,230510,230524,230422,230419,230418,230323,230308,230303,230216,221016,221206,220510,220524,221202,221013,221013,221022,221010,221024,221008,221202,221026,221007,221205,221114,220720,221128,221127,221127,221009,221009,221127,220904,220904,220825,220825,220507,220912,0002626702,220508,220522,220522,220508,220517,220808,220517,211218,211218,220602,220305,220303,220303,220303,211220,220104,220325,211210,220304,220105,220223,220214,211203,211214,211214,211214,231227,231220,231121,231125,231106,231024,230915,230914,230906,230814,230619,230809,230721,230518,230422,230422,230411,230323,230307,220510,230224,221014,220502,220421,220325,190507,200108,220423,181225,190510,200227,190826,191021,190826,211206,210913,210826,210704,210704,210620,210618,210519,210502,210406,210304,201205,201205,201022,200928,200519,200329,190426,190723,190107,200108,200108,200108,191202,230304,221025,220902,221022,221114,221114,220502,220404,220315,211214,210402,210303,210303,210103,210704,201007,200907,200422,200728,191212,190802,200313,191022,210903,210325,210117,201022,191220,190725,200312,191223,200518,201029,201029,200422,200422,190415,200511,191223,190219,200704,201007,181113,181228,200305,190507,190109,200413,191213,200108,191111,200615,200107,190422,190422,200331,190623,200617,200615,200302,200416,190325,200519,191228,190325,200317,190218,200603,190716,181218,200617,200413,190219,200103,200320,190306,211206,211011,211109,211012,
Risk classification
Class II
Area (FDA)
device
Country
United States

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