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Recall Observatory FDA recall evidence

Device product

Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features 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.

Z-0995-2018

November 27, 2017

Class II

Product summary

Firm
Arrow International Inc
Event
Event 79339
Status
Terminated
Classification
Class II
Quantity
23,904 in total
Official record key
device-enforcement:Z-0995-2018

Official wording

Reason: 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.

Code information: ASK-42703-PRJ 13F16L0007 13F16M0013 13F17A0296 13F17D0110 13F17F0319

Distribution pattern: US in the states of OH, FL, SC, TX, KY, NJ, MI

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.