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Terminated

Arrow Three-Lumen CVC

FDA Recall Z-1290-2022 · Posted 2022-06-27

Recalling FirmARROW INTERNATIONAL Inc.
Recall StatusTerminated
Product CodeFOZ
Date Initiated2022-05-05
Date Terminated2024-09-04
Product Quantity10,301 units

Reason for Recall

Gravity flow rates on the affected product lidstock are incorrect.

Firm Action

A recall notification was issued to the consignee on 05/05/2022 via FedEx 2-day mail. The letter instructs the consignee to check the inventory, place a copy of the letter with all affected product and return the response form if the consignee is a medical facility. If the consignee is a distributor, the letter instructs the consignee to provide the notice to their customers, check the inventory, return the completed response form. An updated notification was sent on about 08/09/2022, via FedEx. The updated notification provided an additional description of the label error. Product scope remains the same.

Root Cause

Error in labeling

Distribution Pattern

US Nationwide distribution in the states of Florida.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K970864ARROW-HOWES LARGE BORE MULTI-LUMEN CENTRAL VENOUS CATHETERSArrow Intl., Inc. · 1997-10-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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