Terminated

Edwards LifeSciences, Percutaneous Sheath Introducer Set, Rx only, For single use only. Indicated for use in patients requiring access of the venous system or to facilitate catheter insertion.

FDA Recall Z-1913-2009 · Posted 2009-08-25

Recalling FirmEdwards Lifesciences, Llc

Recall StatusTerminated

Product CodeDYB

Date Initiated2009-05-11

Date Terminated2012-02-23

Product Quantity67,357 Units

Reason for Recall

Edwards LifeSciences LLC received several complaints, in which the blue connector of the introducer assembly has broken (fracture/separation) after several hours of use.

Firm Action

Edwards LifeSciences LLC initiated the worldwide recall via customer letters dated May 11, 2009 and are being sent by Federal Express stating that customers cease using affected product from the indicated lots and return all unused products. The firm requested that the customer provide written verification of stock and identify any unused product to be returned. For further information, contact Edwards LifeSciences LLC Customer Service at 1-800-424-3278.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution: United States (AL, AR, CA, CO, CT, DC, FL, GA, IA, IL, IN,KS, KY, MA, MD, ME, MI, MO, MS, ND, NH, NJ, NM, NV, NY, OH, PA, RI, SC, TN, TX, VA, WV, HI and PR), Austria, Canada, Switzerland, Czech,republic, Germany, Denmark, Algeria, Estonia, Egypt, Spain, Finland, France, Great Britain, Hungary, Iceland, Ireland, Italy, Kuwait, Lithuania, Luxembourg, Latvia, Netherlands, Norway, Poland, Portugal, Romania, Russia, Sweden, Slovak republic, Tunisia, Turkey, Aruba, Hong Kong, Malaysia and Singapore.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K981909BAXTER HEMOSTASIS VALVE INTRODUCERSBaxter Edwards · 1998-11-24

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.