—#126904

Product

Arrow Percutaneous Sheath Introducer Kits The Percutaneous sheath introducer products permit venous or arterial access and device introduction to the central circulation.

FDA product code: DYB — Introducer, Catheter
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K780532
Affected lot / code info: Product codes and lot numbers: AK-09903-A 23F13G0162 AK-09903-S RF3064511 CDC-09903-1A 23F13G0642 AK-09903-J 23F13G0400 ASK-09903-CMC RF3064673 NL-09903-S 23F13G0630 AK-09903-LFSP RF3065449 ASK-09903-CMC 23F13G0343 NR-09903-S 23F13G0180 AK-09903-S 23F13G0204 ASK-09903-NKC 23F13G0336 SI-09903-E RF3064710 AK-09903-S RF3064956 ASK-09903-TJ 23F13G0567 SI-09903-E RF3064915 AK-09903-S 23F13H0195 CDC-09903-1A RF3065316

Why it was recalled

Arrow is recalling the Arrow Percutaneous Sheath Introducer Kits due to dilator tip damage noted during internal inspection. Dilator tip damage has the potential to result in vessel damage.

Root cause (FDA determination)

Process control

Action the firm took

Teleflex/Arrow International sent an Urgent Medical Device Recall Notification letter dated April 17, 2014, to distributors and end users. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use and quarantine any affected product and to complete the enclosed Recall Acknowledgement Form and fax it to 1-800-343-2935 to return product. Customers would be contacted by a customer service representative for a Return Goods Authorization (RGA) Numbers and would be provided instructions for the return of the product. Customers should complete the form whether they have affected product or not. Customers with questions were instructed to call 1-800-343-2935. For questions regarding this recall call 610-378-0131.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide) and Canada.

Timeline

Recall initiated: 2014-04-14
Posted by FDA: 2014-06-04
Terminated: 2016-10-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #126904. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.