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Recall Observatory FDA recall evidence

Device product

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.

Z-1003-2018

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-1003-2018

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: CDA-42703-P1A 13F16L0092 13F17A0022 13F17A0301 13F17C0266 13F17D0039 13F17F0299 13F17H0071

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.