—#132005

Product

The Arrow Edge Hemodialysis Catheterization Set Long-Term Access and NextStep Antegrade Hemodialysis Catheterization Set, Long-Term Access, part numbers: AC-15192-SFX, AC-15232-SFX, AC-15272-SFX, AC-15312-SFX, AC-15422-SFX, CS-15192-SFX, CS-15192-SFXM, CS-15232-SFX, CS-15242-I, CS-15272-SFX, CS-15282-I, CS-15312-SFX, CS-15322-I, CS-15362-I, CS-15422-SFX, CS-15502-SFX, CS-15552-I, CSD-15242-I, CSD-15282-I, and CSD-15322-I. The Arrow Edge Hemodialysis Catheterization Set and NextStep Antegrade Hemodialysis Catheterization Set is indicated for use in 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: K111117, K111900
Affected lot / code info: Lot numbers: RF2095946, RF2056557, RF2058764, RF2060829, RF2084897, RF2084162, RF2071325,RF2060831, RF2083836, RF2096027, RF2107409, RF2108329, RF2119933, RF2060836, RF2060899, RF2083837, RF2084898, RF2107410, RF2108324, RF2071317, RF2121827, RF2058355, RF2060414, RF2108326, RF2060811, RF2110441, RF2069798, RF2121821, RF2069964, RF2122497, RF2110442, RF2058357, RF2119935, RF2108330, RF2121820, RF2057719, RF2056545, RF2111259, RF2096348.

Why it was recalled

The tunneling sheath packaged within the kits can crack during placement. If the tunneling sheath cracks, it can cause a delay in treatment for the time it takes to retrieve a replacement kit.

Root cause (FDA determination)

Component design/selection

Action the firm took

An Urgent Medical Device Recall Notification letter, dated February 4, 2014, was sent to direct consignees that identified the product, problem, and action to be taken. Customers were asked to discontinue use and quarantine affected inventory. The Recall Acknowledgement form should be completed and faxed back to 1-800-343-2935. A customer service representative will contact customers with a Return Goods Authorization (RGA) Number and provide instructions for the return of the product. Customers are asked to contact their local sales representative or Customer Service at 1-800-343-2935 with questions.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution -- US and Canada.

Timeline

Recall initiated: 2013-02-04
Posted by FDA: 2015-01-22
Terminated: 2016-10-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #132005. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.