Cordis Corporation

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

Cardiovascular Devices

2

No

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.

Product is Cordis Brite Tip Catheter Sheath Introducer (4, 7, 8, 9, 10 and 11French sizes only).

All lot numbers for the referenced product numbers.

Gastroenterology-Urology Devices

2

Yes

Product was distributed to 1141 user/medical facilities nationwide.

The device is Labeled as SMART Control TRANSHEPATIC BILIARY STENT REF (PRODUCT NUMBER LISTED), VARIOUS LABELED SIZES . and lot numbers. || Product is packed in a Tyvek pouch and further packed into a shelf carton. || Product Numbers: C06020SB, C06020MB, C06030SB, C06030MB, C06040SB, C06040MB, C06060SB, CO6060MB, C06080SB, C06080MB, C06100SB, C06100MB, C07020SB, C07020MB, C07030SB, C07030MB, C07040SB, C07040MB, C07060SB, C07060MB, C07080SB, C07080MB, C07100SB, CO7100MB, C08020SB, C08020MB, CO8030SB, C08030MB, C08040SB, C08040MB, C08060SB, C08060MB, C08080SB, C08080MB, C08100SB, C08100MB, C09020SB, C09020MB, C09030SB, C09030MB, C09040SB, C09040MB, C09060SB, C09060MB, C09080SB, C09080NB, C10020SB, C10020MB, C10030SB, C10030MB, C10040SB, C10040MB, C10060SB, C10060MB, C10080SB, C10080MB. || Product number related to dimension as follows: || C06020SB 6mm x 20mm x 80cm || C06020MB 6mm x 20mm x 120cm || C06030SB 6mm x 30mm x 80cm || C06030MB 6mm x 30mm x 120cm || C06040SB 6mm x 40mm x 80cm || C06040MB 6mm x 40mm x 120cm || C06060SB 6mm x 60mm x 80cm || C06060MB 6mm x 60mm x 120cm || C06080SB 6mm x 80mm x 80cm || C06080MB 6mm x 80mm x 120cm || C06100SB 6mm x 100mm x 80cm || C06100MB 6mm x 100mm x 120cm || C07020SB 7mm x 20mm x 80cm || C07020MB 7mm x 20mm x 120cm || C07030SB 7mm x 30mm x 80cm || C07030MB 7mm x 30mm x 120cm || C07040SB 7mm x 40mm x 80cm || C07040MB 7mm x 40mm x 120cm || C07060SB 7mm x 60mm x 80cm || C07060MB 7mm x 60mm x 120cm || C07080SB 7mm x 80mm x 80cm || C07080MB 7mm x 80mm x 120cm || C07100SB 7mm x 100mm x 80cm || C07100MB 7mm x 100mm x 120cm || C08020SB 8mm x 20mm x 80cm || C08020MB 8mm x 20mm x 120cm || C08030SB 8mm x 30mm x 80cm || C08030MB 8mm x 30mm x 120cm || C08040SB 8mm x 40mm x 80cm || C08040MB 8mm x 40mm x 120cm || C08060SB 8mm x 60mm x 80cm || C08060MB 8mm x 60mm x 120cm || C08080SB 8mm x 80mm x 80cm || C08080MB 8mm x 80mm x 120cm || C08100SB 8mm x 100mm x 80cm || C08100MB 8mm x 100mm x 120cm || C09020SB 9mm x 20mm x 80cm || C09020MB 9mm x 20mm x 120cm || C09030SB 9mm x 30mm x 80cm || C09030MB 9mm x 30mm x 120cm || C09040SB 9mm x 40mm x 80cm || C09040MB 9mm x 40mm x 120cm || C09060SB 9mm x 60mm x 80cm || C09060MB 9mm x 60mm x 120cm || C09080SB 9mm x 80mm x 80cm || C09080MB 9mm x 80mm x 120cm || C10020SB 10mm x 20mm x 80cm || C10020MB 10mm x 20mm x 120cm || C10030SB 10mm x 30mm x 80cm || C10030MB 10mm x 30mm x 120cm || C10040SB 10mm x 40mm x 80cm || C10040MB 10mm x 40mm x 120cm || C10060SB 10mm x 60mm x 80cm || C10060MB 10mm x 60mm x 120cm || C10080SB 10mm x 80mm x 80cm || C10080MB 10mm x 80mm x 120cm

All lot numbers of the indicated Product/Catalog numbers.

Gastroenterology-Urology Devices

2

Yes

Product was distributed to 620 hospital accounts nationwide. The firm did not provide information on international accounts. This info was requested from firm and RES will be updated when available.

Product is packaged and labeled as: ''Cordis PRECISE Nitinol Stent Transhepatic Billiary System'', Catalog Nos. N820SB, N830SB, N840SB, N920SB, N930SB, N940SB, N1020SB, N1030SB, N1040SB only. This recall also affects Cordis PRECISE Nitinol Stent System, not distributed in the United States, Catalog numbers, N920SC, N930SC, N940SC, N1020SC, N1030SC and N1040SC only.