All Recalls

Defective container: defect prevents product from dispensing as intended.

Microbial contamination of non-sterile product: FDA laboratory analysis found product to contain microbial contamination identified as Providencia rettgeri.

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Defective Delivery System: Customer complaints received for ripping patches and tight release/adhesive transfer.

Microbial contamination of non-sterile product: FDA laboratory analysis found product to contain elevated levels of yeast and mold as well as the presence of Bacillus cereus.

Defective Delivery System: Potential defect that could prevent the product from dispensing as intended.

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Superpotent: High Out of specification (OOS) test result for percent label claim (%LC).

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

CGMP Deviations

CT operation may be restricted by an interlock which is a result of an system error and the CT system may stop operating properly after an attempt to cancel the error message has been initiated.

Due to interference with the Live Listen feature of hearing aid or AirPods, the user's iPhone may perform automatic processing of the urination sound signal, resulting in lower urination volume and velocity values than expected.

Backup batteries can fail earlier than their estimated life.

The instrument is incorrectly color coded.

The product is not able to provide irrigation.

A video signal from one of the transceivers of the Large Display may be lost. In very rare cases, both transceivers of the Large Display could potentially fail which can lead to the loss of both video signals. This issue can sporadically affect the Large Display in the examination room as well as the displays in the control room.

Paint particles may detach and fall in the operating field. In the worst case scenario, infection, organ irritation, hypersensitivity reaction, and tissue granuloma may result if paint particles fall during surgical operation into the patient body or in the operating field.

An issue has been identified with Phillips (Emergin) and Longleaf non relay (Connexall, Vocera, Cerner) wireless integrations used with NaviCare/Voalte Nurse Call, software versions 3.9.100 through 3.9.300. Calls placed from a push button call device, such as a push button switch, call cord, or from the push buttons on a room audio station, will be canceled on the nurse call system when the call is answered at the wireless phone, regardless of the call priority.

Dialyzers were distributed after being exposed to cold temperatures which exceeded the low-temperature range in the firm's standard operating procedure.