—#155538

Product

Arrow Multi-Lumen CVC Kit The Arrow Two-Lumen Central Venous Access device permits venous access and catheter introduction to the central circulation.

FDA product code: DQY — Catheter, Percutaneous
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K862056
Affected lot / code info: Material number: CDC-12703-1A, CDC-12802-1A, CDC-15703-1A, CDC-15703-B1A, CDC-15802-1A, Device Listing E426708

Why it was recalled

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

Root cause (FDA determination)

Packaging

Action the firm took

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.

Recalling firm

Firm: Arrow International Inc
Address: 2400 Bernville Rd, Reading, Pennsylvania 19605-9607

Distribution

Distribution pattern: Worldwide Distribution - US (nationwide) and Canada

Timeline

Recall initiated: 2017-05-09
Terminated: 2018-09-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #155538. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.