ARROWg+ard Blue CVC Kit The ARROWg+ard Blue CVCs are intended to permit venous access to the central circulation
FDA Recall Z-2337-2017 · Posted None
Advertisement
Recalling FirmArrow International Inc
Recall StatusTerminated
Product CodeFOZ
Date Initiated2017-05-09
Date Terminated2018-09-17
Product Quantity27,485 units distributed in U.S., 4,371 units distributed internationally
Reason for Recall
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 components infusions
-infusion of incompatible medications
-central venous pressure monitoring
lack of usable peripheral IV sites
-replacement of multiple peripheral sites for IV access
Firm Action
Arrow International sent an Urgent Medical Device Recall Notification Letter dated May 11, 2017, to affected customers. The firm's notification letter is requesting that customers immediately assess their current inventory and to discontinue and quarantine any product with the specific lot codes listed in the letter. In addition, customers were asked to complete the Recall Acknowledgement form and fax or email it back to Customer Service so they can receive a Returns Good Authorization Number for the product's return. Customers with questions were instructed to contact their local sales representative or Customer Service at 1-866-246-6990.
Root Cause
Packaging
Distribution Pattern
Worldwide Distribution - US (nationwide) and Canada
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.
Advertisement