As part of our post market surveillance, we recognized that some customers are using flammable freezing sprays within the cryostat chamber. All flammable freezing sprays can potentially ignite and therefore can cause serious injuries. The flammability is indicated on the labelling of these sprays. The cryostat labelling, however, did not include any specific warning about usage of flammable freezing sprays prior to 2019.
Reason for recall: As part of our post market surveillance, we recognized that some customers are using flammable freezing sprays within the cryostat chamber. All flammable freezing sprays can potentially ignite and therefore can cause serious injuries. The flammability is indicated on the labelling of these sprays. The cryostat labelling, however, did not include any specific warning about usage of flammable freezing sprays prior to 2019. Distribution: US Nationwide distribution. Quantity: 13 units Lot/code info: a) Material Number 1491510C002, UDI/DI (01)04049188002945, Serial Numbers: 5359022006, 5367012006, 5913, 5996, 5065, 5625022007, 5467072006, 5901, 5108122004, 5330, 5269, 5667; b) Material Number 1491510C003, UDI/DI (01)04049188002891. Serial Numbers: 5537
04049188002945, 04049188002891
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.