Edwards Lifesciences, LLC: Fogarty Arterial Embolectomy Catheters Model Number: 120602FP 120403FP 120803FP 120404FP 120804FP 120805FP 120806FP 120807FP Fogarty Arterial Embolectomy Catheter with Style

Hazard

Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches.

Details from the source

Reason for recall: Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches. Distribution: Worldwide distribution - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Albania, Argentina, Australia, Austria, Bahamas, Bahrain, Belgium, Bulgaria, CANA Quantity: 715,620 units Lot/code info: Fogarty Arterial 120403FP Embolectomy Catheters Model Number / UDI-DI Code: 120602FP / 00690103205206 Lot Numbers: 63325817 63412990 64049166 64052416 64320468 64311217 64286041 64075556 64085285 64124889 64180619 63914203 63967960 63266275 63281593 63449645 63560630 63612077 63626926 63738860 63735762 63750304 63772968 63724845 63914201 63892007 63967950 63990050 64027881 64036551 64052415 64063487 64124888 64173669 64180620 64180548 64332505 64344742 63907174 64099010 64099008 63420190 63435603 63476159 63511721 63600508 63611742 63669399 63750303 63735818 63850952 63907175 63944429 63984736 63944467 63907167 64014108 63995701 64036698 64075555 64180549 64173668 64110676 64205522 64220842 64252735 64231811 64231810 64264792 64274428 64297806 64297810 64321021 64321020 63281591 63375216 63420189 63464807 63501933 63560629 63634785 63612076 63914359 64193163 64266393 64239056 63375217 64059266 64252737 63735761 63412989 63600507 63633312 63990049 64193162 64205539 64383524 64394451 63611743 63352974 63386855 63340743 63349810 63432009 63449644 63476158 63435604 63487678 63464806 63513249 63612073 63612074 63560631 63669400 63612075 63661028 63670579 63670029 63670031 63712780 63687299 63712779 63670028 63776322 63797464 63892006 63850950 63856376 63883760 63883761 63944427 63954394 63990047 63990048 64025093 64063485 64099009 64180550 64383526 64243759 64205521 64273885 64239057 64276520 64252736 64274714 64297805 64264793 64286039 64343086 64354938 64368268 64368267 64085286

UPC codes

00690103205206, 00690103205084, 00690103205091, 00690103205107, 00690103205213, 00690103205220, 00690103205237, 00690103201789, 00690103205190, 00690103205244

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.