—#101741

Product

Arrow NextStep Antegrade Chronic Hemodialysis Catheter. Product is used for attaining long-term vascular access for hemodialysis and apheresis.

FDA product code: MSD — Catheter, Hemodialysis, Implanted
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K102238
Affected lot / code info: Product Number CS-15192-IXM, Lot Number RV1034909; Product Number CS-15232-IXM, Lot Number RV1034911; Product Number CS-15272-IXM, Lot Number RV1034912; Product Number CS-15312-IXM, Lot Number RV1034913; Product Number CS-15422-IX, Lot Number RV1034914; and Product Number CS-15502-IX, Lot Number RV1034915.

Why it was recalled

Firm has received complaints indicating breakage and/or separation of the stylet within the Arrow(R) NextStep(R) Antegrade Catheters.

Root cause (FDA determination)

Device Design

Action the firm took

An "Urgent Medical Device Recall" letter dated June 28, 2011 was issued to consignees. The letter requested that customers check their stock, cease use and distribution, and quarantine all affected product. Consignees were further directed to complete the "Recall Acknowledgement & Stock Status Form", return the form to their sales representative, and return affected product as instructed on the letter. For questions or concerns, call 1-800-233-3187.

Recalling firm

Firm: Arrow International Inc
Address: 2400 Bernville Road, Reading, Pennsylvania 19605

Distribution

Distribution pattern: United States (states of CA, DE, FL, MI, NC, and TN).

Timeline

Recall initiated: 2011-06-28
Posted by FDA: 2011-07-30
Terminated: 2012-04-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #101741. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.