Recalls / —
—#155536
Product
1) ARROWg+ard Blue You-Blend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions The large-bore two-lumen catheter permits venous access to the central circulation for rapid fluid administration, temporary or acute hemodialysis, apheresis and hemofiltration. It may be inserted into the jugular, subclavia, or femoral veins Catheter, hemodialysis non-implanted
- FDA product code
- MPB — Catheter, Hemodialysis, Non-Implanted
- Device class
- Class 2
- Medical specialty
- Gastroenterology, Urology
- 510(k) numbers
- K993933
- Affected lot / code info
- Material number: CDA-22122-U1A, CDC-22141-1A CDC-26142-1A Device Listing D025726
Why it was recalled
Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
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 #155536. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.