Class 2 Device Recall Cordis Brite Tip Sheath

• Date Initiated by Firm: May 05, 2003
• Date Posted: June 12, 2003
• Recall Status: Terminated on November 19, 2008
• Recall Number: Z-0941-03
• Recall Event ID: 26333
• 510(K)Number: K954595 K971608 K984500
• Product Classification: Introducer, Catheter - Product Code DYB
• Product: Product is Cordis Brite Tip Catheter Sheath Introducer (4, 7, 8, 9, 10 and 11French sizes only).
• Code Information: Catalog# Lot# 401011M 40102114 40202950 40302315 40502170 41002991 41101111 41201721 41201898 50102160 50402054 50402323 50502275 51002576 A0202879 A0402425 A0402809 A0702953 A0801019 A0801298 A1001609 A1201755 X0102305 X0202591 X0302562 X0602226 X0702049 X0702828 X1001444 X1101158 X1101717 X1102221 401023M 40202378 40302816 40502368 40602515 41001756 41201511 50102176 50203192 50402141 A0202574 A0402445 A0502351 A0702965 A0801240 A0901911 A1002290 A1101856 A1102652 A1201677 X0103383 X0202812 X0402634 X0502655 X0602239 X0701056 X0702030 X0702835 X0902137 X1001459 X1101732 X1102232 401111M 40502481 40602534 40702040 50402324 50502276 A0202594 A0302241 A0402426 A0602559 A1002395 A1102643 X0102205 X0702829 X0802537 X1002704 X1102222 401123M 40402551 40702044 40802500 41001594 41201512 50102177 A0402446 A0402838 A0602028 A0602993 A1002394 X0202203 X0402153 X0702681 X0802538 X1002710 X1101733 X1102233 401411M 40103569 40202627 40302787 40402428 40502480 40702374 40802560 40902254 41102289 50402319 50502185 51002745 A0102998 A0202144 A0302242 A0402106 A0502325 A0502657 A0602560 A0702426 A0802945 A1002430 X0102344 X0102699 X0202733 X0302563 X0402853 X0502338 X0502860 X0602227 X0702018 X0702845 X0902258 X1002350 X1002880 X1102288 401423M 40103715 401705M 40402546 40502497 A0502183 X0402129 X0402899 X0502771 401711M 40402115 40402549 40502865 50502280 A0502184 A0502867 A0602982 X0402147 X0402884 X0502772 X0602231 401723M 40402919 A0502196 A0502333 A0502828 A0602031 X0302684 X0402155 X0402990 X0502658 401735M K0402526 K0502292 K0602023 K0602118 401745M A0502823 X0402984 X0502345 X0502651 401755M A0502824 401790M A0502825 X0402985 X0502346 X0502653 401805M 40502356 40502791 40702534 41102050 50702455 51002382 51102323 X0502531 X0802151 401811M 40102003 40102637 40102866 40202479 40302143 40302827 40402550 40602096 40602369 40702580 40802491 41001442 41001742 41002796 41101500 41102051 41201547 41201901 50102161 50402539 50502281 50702456 51002383 51102324 A0203173 A0402306 A0402691 A0702331 A0702882 A0902986 A1002995 A1101812 A1102587 A1201316 A1201519 X0102306 X0202595 X0402131 X0402900 X0702325 X0802152 X1001304 X1002705 X1101162 X1102150 401823M 40102668 40202125 40202903 40302818 40602519 40702590 40802496 40902776 41002006 41002855 50702465 50802091 51002392 51102363 A0202456 A0302937 A0402096 A0402638 A0402698 A0602032 A0602995 A0702891 A0902146 A1002291 A1102596 X0202603 X0202814 X0402050 X0402991 X0502520 X0602242 X0702033 X0802190 X0902537 X1002711 X1102160 401835M 40602372 40702588 A0502826 A0602582 A0902893 A1102593 X0502516 X0802187 401845M 40102666 40302815 41001775 41002004 41102062 41201510 A0202572 A0302248 A0402697 A0502827 A0602583 A0702888 X0402161 X0502517 X0702027 X0802953 401855M 51102362 A0302931 A0702341 A0902894 A1102594 X0402643 X0502518 X0702910 X0802188 401890M 40402408 40802495 A0602584 A0702890 A0902145 A0902895 A1102595 X0103287 X0302897 X0402986 X0502519 401911M 40102867 40402116 40602535 40702041 40902061 41002797 41002992 51002560 A0502186 A0502868 A0802844 A0902135 A0902987 A1002281 A1002411 A1102644 A1202285 X0202181 X0402617 X0402901 X0502340 X0502773 X0602232 X0602759 X0702673 X0702830 X0802396 X0902530 X1101719 X1102151 401923M 40302826 40602520 40902071 41002308 41002856 41002998 41101524 41201515 51002563 A0202577 A0502530 A0602033 A0702966 A1102653 A1102784 A1201681 X0102326 X0402636 X0402992 X1102161 401935M 40502195 41001777 51002562 A0402444 A0702964 A1002392 A1101831 A1202287 X0202202 X0502654 X0702028 X0802954 X1101753 401945M 40502196 41201746 A0602585 A0802847 A1102650 A1202288 X1101580 401955M 40902070 A1102651 X0402633 X0602765 X0802955 MODS06488 K0502660 MODS10122 L0602168 MODS11269 K0702339 K0902002 MODS12042 K0702514 MODS12295 K0802477 MODS14028 L0502767 MODS15034 50502387 MODS16386 K0502078 MODS17833 K0802476 SRA0140 X0702988 SRAM09555 L0602445 SRAM16514 L0902398
• Recalling Firm/ Manufacturer: Cordis Corporation; 14201 NW 60th Ave; Miami Lakes FL 33014
• For Additional Information Contact: Hal Delgado; 786-313-2000
• Manufacturer Reason for Recall: Reports of broken or separated tips of the catheter sheath introducers.
• FDA Determined Cause: Other
• Action: Cordis provided their national sales force with a recall package for each customer for that representative's area for visits on 5/5/2003. The sales reps were to visit each hospital/medical facitliy to present them with the Recall Letter (dated 5/5/2003) and also a Question and Answer Sheet. The sales rep will search and quarantine for return all involved products in the customers inventory. The sales representative and customer will fill out and sign response forms and return them and the recalled product to 'Cordis Returned Goods' in Miami Lakes, FL. Due to delays in completing the visits the firm sent the same Recall Letter to all accounts that had not been visited yet on 5/30/03. In addition the Sales Reps will still visit the remaining accounts and recover recalled product.
• Quantity in Commerce: 49,022
• Distribution: Product was distributed nationwide to 1057 hospital/medical facitilites including 33 military/VA hospitals. In addition recalled product was distributed to 7 related International Distributors in The Netherlands, Brazil, Canada, Chile, Columbia, Mexico and Venezuela.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DYB