Medical Devices Recalls

Potential breach in the sterility barrier for tray ring covers.

Products do not meet length and diameter specifications.

Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results

Misprinted expiration date on the shelf-box

During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got mixed into other lots.

Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results

GF-UC140P-AL5 is no longer a compatible endoscope for reprocessing in the OER-Pro and presents an infection control risk to patients

When updating BD Kiestra customers to BD Synapsys version 4.10, the custom antibiotic codes set by the customer are overwritten with the BD default antibiotic codes.

System software v1.5.1 has a system software issue related to the Daylight Savings Time (DST) change that can cause a system error, requiring the user to restart the system and potentially cause a delay in treatment

Product labeled incorrectly. The lot was labeled with Small footprint when the product was Medium.

During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got mixed into other lots.

Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results

The product was distributed without FDA authorization or clearance for marketing and distribution in the US.

Kits contained recalled acetaminophen.

Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results

Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results

In the Azurion system, the user can add a new study to a patient by selecting the option Add Study . The Add Study dialogue box is then displayed where the Patient Type is selected to perform the study. Due to a software defect, when the study is initiated by pressing Start Procedure , the Patient Type changes inadvertently to a Patient Type different than the one selected as shown in the Table below. Patient type is one of the factors involved in the dose control process. The incorrect patient type changes the technique factors to be used by the system without notification to the user.

As a result of complaint data review, it identified tissue pushout events occurring during firing of the SureForm stapler when tissue is pushed distally within the jaws, rather than being held in place and transected. Overall rate of harm associated with bleeding of critical severity exceeds the predicted likelihood of harm as documented within Intuitives existing risk documentation.

Point of Care (PoC) rapid test products were distributed to customers who did not have a valid CLIA ID.

Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia