Stryker Sustainability Solutions Recalls

Hazard: Diagnostic electrophysiology (EP) catheters do not meet testing requirements.

Hazard: 39-inche-wide inflatable air transfer mattress packages contain 34-Inch-wide mattresses, so there may be a decreased surface area available to distribute the patient's weight across, which may increase the effort exerted by staff for a lateral patient transfer, and there may be increased friction and shearing forces when the patient is moved resulting in skin tear injury.

Hazard: Through complaint surveillance, it was identified that reprocessed Deep vein thrombosis (DVT) Compression Sleeves may be mislabeled and/or mispackaged.

Hazard: Increased incidence of disposable tourniquet cuffs "not able to achieve desired pressure" and "not holding pressure" due to 1) Cuff fabric tearing during use, and 2) Pinched or unseated O-ring at the connection between the cuff, disposable fill line, and/or cuff hosing, which may lead to loss of vascular occlusion, which may lead to operative site blood loss, hemorrhage, or other complications.

Hazard: Mislabeling; dual-bladder tourniquet cuffs are labeled as single-bladder inflatable cuffs.

Hazard: Product was distributed without receiving regulatory clearance.

Hazard: A subset of temporary intracardiac ultrasound catheters are labeled with the incorrect expiration date. They are mislabeled as having a shelf life of two years, while the actual shelf life is one year. The earliest affected product will expire in May 2020. Use of mislabeled devices may lead to hazards sterility breach, component breakdown or delay in treatment.

Hazard: Tourniquet cuffs are potentially mislabeled. If used may lead to (1) Device misuse during procedure (2) Inadequate Limb Compression Force.

Hazard: Affected lots of reprocessed arthroscopic shavers may display the incorrect catalog number and speed settings when connected to the generator, require manual mode for use on CORE generators, or display an error message on Crossfire 1 and 2 generators which does not allow the device to be used.

Hazard: Stryker s Sustainability Solutions division (SSS) has received an increase in reports indicating that an EEPROM chip error code may occur when Reprocessed 2515 NAV eco Variable Electrophysiology (EP) Catheters are used with CARTO(R) EP Navigation Systems.

Hazard: Through investigation, it was determined that H12LP Trocars in scope of a previous H12LP recall were distributed to facilities within the distribution chain following the recall execution activities initially performed by distributor.

Hazard: Electrophysiology catheters were identified to be item # D134903 and distributed. It was subsequently determined that these catheters are item # D134909, which is not approved for reprocessing.

Hazard: Stryker Sustainability Solutions has received an increase in reports indicating that the affected Reprocessed HARH36 devices may display an error code (No Instrument Uses Remaining) upon initial connection to the generator. When this error code is present, the device is not able to be used.

Hazard: Thrombogenicity test results demonstrated that both the test devices (SSS) and control devices (OM) did not meet the internal specification of non-thrombogenic .

Hazard: An EEPROM chip error code may occur when the catheters are used with CARTO EP Navigation Systems.

Hazard: An EEPROM chip error code may occur when the catheters are used with CARTO EP Navigation Systems.

Hazard: 3040 compression sleeves being mislabeled as a 3010-PL compression sleeves.

Hazard: A breach in the sterile packaging may have occurred resulting in potentially non-sterile product.

Hazard: A breach in the sterile packaging may have occurred resulting in potentially non-sterile product.

Hazard: An increase in reports indicating that the reprocessed H12LP Trocar adjustable plug may break in the packaging or during use.

Hazard: The EP Catheters may be mislabeled for French size during reprocessing.

Hazard: Issue with the process for detection of leaking Pressure Tourniquet Cuffs (PTC). Leaking PTC devices may result in excessive blood loss requiring surgical or medical intervention or systemic leakage of local anesthetic during Bier Block requiring medical intervention.

Hazard: Product defect; tip of two (2) Angiographic Catheters model # 10732203 broke off, prior to being used on the patient.

Hazard: Mislabeled for size

Hazard: Device packaging may not be sealed.

Hazard: Device packaging may not be sealed.

Hazard: Reprocessed Stryker Pressure Tourniquet Cuffs were mislabeled, including some labeled as single port when they contained dual port, and vice versa.

Hazard: Stryker Sustainability Solutions is recalling the Fuhrman Pleural & Pneumopericardial Drainage Set due to receiving complaints that it broke off in the pleural cavity while inserting the device into the patient.

Hazard: It was reported that packaging was not properly sealed.

Hazard: Stryker Sustainability Solutions has received reports indicating that devices from one lot (lot# 3574704) were labeled as 100mm models (CB5LT) while the devices inside of the packaging were 75mm models (CB5ST).