Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

Medline Convenience Kits:

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL

Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured

COOK MEDICAL Cook Spectrum Central Venous Catheter Tray: Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0003, Order Number G56424;

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

COOK MEDICAL Spectrum Central Venous Catheter Set: Reference Part Number C-UDLM-401J-ABRM-HC, Order Number G43983;

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

COOK MEDICAL Spectrum Central Venous Tray: Reference Part Number C-UQLMYJ-1001J-RSC-ABRM-HC-FST-A-RD, Order Number G44800;

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

Medline Convenience Kits:

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

REF: 381423, BD Insyte Autoguard, Shielded IV Catheter, 22GA X 1.00 IN (0.9 X 25 MM) 35mL/min, STERILEEO, RxONLY

Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.

REF: 382633, BD Insyte Autoguard BC Winged, Shielded IV Catheter with Blood Control Technology, 20GA x 1.00 in (1.1x25 mm) 63 mL/min, STERILEEO, RxOnly

Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.

REF: 381533, BD Insyte Autoguard Winged, Shielded IV Catheter, 20 GA x 1.00 in (1.1 x 25 mm) 65mL/min, STERILEEO,RxOnly

Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.

REF: 381433, BD Insyte Autoguard Shielded IV Catheter, 20GA x 1.00 in (1.1x25 mm) 65 mL/min, STERILEEO, RxOnly

Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.