Recall database
The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Chiesi USA recalled 7,235 Curosurf vials distributed nationwide to hospitals and clinics. The recall cites a lack of assurance of sterility. Healthcare providers should stop using the product immediately and contact Chiesi USA for guidance.
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Convenience kit contains a syringe in which the rotating adapter may unwind during use, resulting in a loose connection and/or full disconnection between the syringe and manifold"
Packaging integrity issue that may compromise product quality .
Metal fragments. The potential foreign object is a hard, metal (stainless steel), curled spring. Dimensions of a similar spring measure 2.27mm in cross-sectional thickness and 25.38mm in coil width. Spring ends are not sharp but may be sharp if broken/ cut.