ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER. Product Usage: Indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring cental 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 and injection of contrast media.
FDA Recall Z-2136-2016 · Posted 2016-07-06
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Recalling FirmArrow International Inc
Recall StatusTerminated
Product CodeFOZ
Date Initiated2016-06-02
Date Terminated2017-08-25
Product Quantity1, 170 units
Reason for Recall
Arrow is recalling these products due to the possibility that although the kit is labeled as containing a 20 cm catheter, a 16 cm catheter may be packaged in the kit.
Firm Action
Arrow mailed an Urgent Medical Device Recall Notification letter to customers requesting they immediately discontinue distribution and quarantine any products with the affected lot numbers. A Recall Acknowledgement Form was included with the notification letter for customers to complete and email to recalls @teleflex.com indicating the amount of product on hand.
Root Cause
Process control
Distribution Pattern
US Nationwide Distribution: in the states of MA, CA, IL, TN, IL
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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