Microtek Medical Inc.: 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).

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.

Details from the source

Reason for recall: During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film. Distribution: Distributed nationwide and internationally to Canada, Mexico, New Zealand, Belize, and Hong Kong. Quantity: 135,999 cases (6,799,950 units) Lot/code info: SKU/UDI-Device Identifier: 2002S/00748426002399; Lot Numbers: 200403,211013,210626,200409,190913,200420,200422,200422,190510,190319,200108,190415,190702,190109,190827,191022,200313,200306,200312,191212,190226,190802,181113,181221,191213,191019,200617,181130,190114,200313,190620,191228,211109,211109,211107,211109,211021,211022,211012,211012,211026,211018,211105,211105,211105,211012,211007,210913,210913,210908,210802,210806,210810,210903,210902,210902,210812,210809,210718,210709,210729,210810,210328,210823,210729,210802,210802,210719,210728,210703,210625,210622,210704,210618,210618,210710,210610,210520,210519,210408,210518,210518,210518,210517,210512,210520,210318,210502,210502,210318,210317,210422,210409,210405,210403,210404,210329,210422,210327,210404,210325,210323,210402,210304,210220,210127,210121,210117,201208,201204,201204,201013,201127,201126,201102,201028,201022,201026,200906,200912,200904,200616,201007,190218,190729,190916,200513,200329,190426,181218,181221,200417,200514,200513,190823,190823,191021,190306,181124,191112,191213,191112,190108,190327,191127,190121,191004,191004,190725,200512,190419,200615,200611,190306,190506,191018,190227,190528,181107,190102,200102,181129,190716,190716,190116,181220,181225,181225,181214,190725,210618,181107,231129,200107,210618,181011,181214,181225,200421,190724,191212,200728,190802,190805,200422,191218,190912,191017,191112,200422,200403,190624,200221,190109,191019,190307,190802,181113,190409,190402,200227,190912,190402,181221,191212,190

UPC codes

00748426002399

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.