Z-0998-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 21, 2018
- Initiation Date
- November 27, 2017
- Termination Date
- September 22, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 23,904 in total
Product Description
AGB+ Pressure Injectable Multi- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluids, medications, or chemotherapy infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values frequent blood sampling or blood/blood component infusions infusion of incompatible medications central venous pressure monitoring lack of usable peripheral IV sites replacement of multiple peripheral sites for IV access injection of contrast media When used for pressure injection of contrast media, do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with pressure injectable CVC may not exceed 400 PSI.
Reason for Recall
Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
Distribution Pattern
US in the states of OH, FL, SC, TX, KY, NJ, MI
Code Information
CA-42703-P1A 13F16M0047 13F17B0152 13F16K0302 13F17F0226 13F17H0407 13F17A0157 13F17B0117 13F17C0250 13F17F0259 13F17H0100 13F17C0057 13F17F0298 13F17H0068