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U.S. Department of Health and Human Services

Class 2 Device Recall Hookup Accessories

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  Class 2 Device Recall Hookup Accessories see related information
Date Initiated by Firm November 13, 2023
Date Posted December 22, 2023
Recall Status1 Open3, Classified
Recall Number Z-0617-2024
Recall Event ID 93566
510(K)Number K082988  K172677  K102996  
Product Classification Accessories, cleaning, for endoscope - Product Code FEB
Product Hookup Accessories used with MEDIVATORS ADVANTAGE PLUS and
ADVANTAGE PLUS Pass Thru Automated Endoscope Reprocessors

Model # Model Description
2-8-001 HU ZERO CHANNEL NO LT
2-8-010 ASSY, HOOK-UP, OLYMPUS
2-8-014 HOOKUP, OPTIM LT
2-8-030 ASSY, HOOKUP, PENTAX-0K
2-8-040 ASSY, HKUP STORZ 0K
2-8-070 ASSY, HU VISION SCIENCE
2-8-112 ASSY, HOOKUP OLMPUS 1K
2-8-120 ASSY, HOOKUP FUJI 1K
2-8-210 ASSY, HOOK-UP OLYMPUS 2K
2-8-213 ASSY, HOOKUP, OLYMPUS-2K
2-8-218 ASSY HOOKUP OLY 2K
2-8-236 ASSY, HOOKUP FUJINON 2K
2-8-244 ASSY, HOOKUP, STORZ 2K
2-8-245 ASSY, HOOK-UP, STORZ 2K
2-8-246 ASSY, HKUP, PENTAX-2K
2-8-260 ASSY, HOOK-UP WOLF 2-K
2-8-280 ASSY HOOKUP
2-8-312 ASSY, HOOK-UP OLYMPUS-3K
2-8-330 ASSY, HOOK-UP, PENTAX-3K
2-8-332 ASSEMBLY, HOOK-UP, PENTAX
2-8-334 ASSEMBLY, HOOK-UP, PENTAX
2-8-335 ASSY, HOOKUP, OLYMPUS, 3K
2-8-336 ASSY,HKUP FUJI 70 BRONC
2-8-338 ASSY, HU, FUJI BRONCH U/S
2-8-421 ASSY, HOOKUP, FUJIFILM
2-8-428 ASSY, ED-580XX
2-8-431 ASSY, HOOKUP, PENTAX
2-8-432 ASSY, HOOK-UP, PENTAX
2-8-460 HOOKUP, ASSY WOLF 4K
2-8-511 ASSY, HOOK-UP, OLY
2-8-513 ASSY HOOKUP OLY 4K ESOPHA
2-8-522 ASSY, FUJINON 4K-JET
2-8-523 ASSY, HKUP, FUJI 4K SER 5
2-8-526 ASSY, HOOKUP FUJI 4K+JET
2-8-527 ASSY, FUJI 700 NO FWJ
2-8-528 HOOK, EI-580BT
2-8-534 ASSY, HOOK-UP, PEN-4K+JET
2-8-537 ASSY, HKUP, PTX90 4K+JET
2-8-539 HOOK, PTX I20 FWJ
2-8-540 ASSY-HOOK-UP,STORZ,5K
2-8-611 ASSY, HOOK-UP, OLY
2-8-612 ASSY, HOOKUP, PENTAX
2-8-614 ASM HU OLY TGF-UC180J
2-8-617 ASSY, HKUP, OLY 2 BIOPSY
2-8-623 ASSY,HKUP,FUJI-5 4K+JET
2-8-625 ASSY, HOOKUP, EG-580UT
2-8-626 ASSY, HOOKUP, EG-580UR
2-8-627 ASSY, HKUP, FUJI 700 SER
2-8-634 ASSY, HOOKUP PENTAX DUAL
2-8-639 HOOK, EG3X-J10
2-8-640 ASSY,HOOK-UP STORZ 6K
2-8-711 ASSY, HOOKUP, OLYMPUS 5K
2-8-718 ASSY, HOOKUP, OLY 160/180
2-8-740 ASSY, HOOK-UP, STORZ
2-8-811 ASSY HKUP OLY-ECHO+LIFT
2-8-901 KIT TEE/TOE/RUS HU ADV+
5-8-010 ASSY, HOOKUP DBL LT
5-8-030 ASSY, HOOKUP
5-8-040 ASSY HOOKUP STORZ 0K DBL
5-8-050 ASSY, HOOKUP, DILATOR
5-8-112 HOOKUP 2-SCOPE 1-K
5-8-190 HOOK DBL, IS, ION
5-8-210 ASSY, HOOKUP
5-8-245 HOOKUP KARLSTORZ-2K
2-8-001HAN HU ZERO CHANNEL NO LT
2-8-002HAN ADVANTAGE TEST BLOCK
2-8-010HAN ASSEMBLY, HOOK-UP,OLYMPUS
2-8-030HAN ASSY,HOOKUP,PENTAX-OK
2-8-112HAN ASSY, HOOK-UP OLYMPUS 1K
2-8-160HAN ASSY, ADV HOOKUP, WOLF
2-8-210HAN ASSY, HOOK-UP OLYMPUS 2K
2-8-213HAN ASSY, HOOKUP, OLYMPUS-2K
2-8-218HAN ASSY HOOKUP OLY 2K
2-8-245HAN ASSY, HOOKUP, STORZ-2K
2-8-330HAN ASSY, HOOK-UP, PENTAX-3K
2-8-334HAN ASSEMBLY, HOOK-UP, PENTAX
2-8-335HAN ASSY,HOOKUP,OLYMPUS
2-8-336HAN ASSY,HKUP FUJI 70 BRONC
2-8-338HAN ASSY, HU, FUJI BRONCH U/S
2-8-421HAN ASSY, HOOKUP, FUJINON
2-8-428CAS HOOK, CAS, ED-580XX
2-8-428HAN HOOK, HAN, ED-580XX
2-8-431CAS ASSY, CASSETTE, PENTAX
2-8-431HAN ASSY, HOOK-UP, PENTAX
2-8-511HAN ASSY, HOOK-UP, OLY
2-8-526HAN ASSY, HOOKUP FUJI 4K+JET
2-8-536HAN HOOKUP,PENTAX,70ULT, 5K
2-8-537CAS ASSY,CASS,PTX 90 4K+JET
2-8-537HAN ASSY HKUP,PTX90 4K+JET
2-8-611HAN ASSY, HOOK-UP, OLY
2-8-626CAS ASSY, CASS, FUJINON 580UR
2-8-627HAN ASSY, HAN, FUJI 700 SER
2-8-634CAS ASSY,CASS PENTAX DUAL CH
2-8-634HAN ASSY,HOOKUP PENTAX DUAL
2-8-640HAN ASSY, HOOK-UP STORZ 6K
2-8-711HAN ASSY, HOOKUP, OLYMPUS-5K
2-8-718HAN ASSY,HOOK-UP, OLY 160/180
2-8-811HAN ASSY HKUP OLY-ECHO W/LIFT
2-8-902H HU BLOCK ULTRASOUND PROBE
5-8-030HAN ASSY, HOOKUP
5-8-050HAN ASSY,HOOKUP, DILATOR
5-8-112HAN ASSY, HOOKUP 2-SCOPE 1-K
5-8-244HAN ASSY, HKUP 2K DBL
Code Information Products distributed between July 17 - September 27, 2023 Model # Model Description UDI 2-8-001 HU ZERO CHANNEL NO LT 00677964068515 2-8-010 ASSY, HOOK-UP, OLYMPUS 00677964068478 2-8-014 HOOKUP, OPTIM LT 00677964095177 2-8-030 ASSY, HOOKUP, PENTAX-0K 00677964071348 2-8-040 ASSY, HKUP STORZ 0K 00677964072284 2-8-070 ASSY, HU VISION SCIENCE 00677964094637 2-8-112 ASSY, HOOKUP OLMPUS 1K 00677964071300 2-8-120 ASSY, HOOKUP FUJI 1K 00677964102080 2-8-210 ASSY, HOOK-UP OLYMPUS 2K 00677964068485 2-8-213 ASSY, HOOKUP, OLYMPUS-2K 00677964070648 2-8-218 ASSY HOOKUP OLY 2K 00677964072369 2-8-236 ASSY, HOOKUP FUJINON 2K 00677964072376 2-8-244 ASSY, HOOKUP, STORZ 2K 00677964071836 2-8-245 ASSY, HOOK-UP, STORZ 2K 00677964071195 2-8-246 ASSY, HKUP, PENTAX-2K 00677964084058 2-8-260 ASSY, HOOK-UP WOLF 2-K 00677964105951 2-8-280 ASSY HOOKUP 00677964073069 2-8-312 ASSY, HOOK-UP OLYMPUS-3K 00677964074400 2-8-330 ASSY, HOOK-UP, PENTAX-3K 00677964073816 2-8-332 ASSEMBLY, HOOK-UP, PENTAX 00677964091483 2-8-334 ASSEMBLY, HOOK-UP, PENTAX 00677964073830 2-8-335 ASSY, HOOKUP, OLYMPUS, 3K 00677964071263 2-8-336 ASSY,HKUP FUJI 70 BRONC 00677964091506 2-8-338 ASSY, HU, FUJI BRONCH U/S 00677964074141 2-8-421 ASSY, HOOKUP, FUJIFILM 00677964071270 2-8-428 ASSY, ED-580XX 00677964104923 2-8-431 ASSY, HOOKUP, PENTAX 00677964071706 2-8-432 ASSY, HOOK-UP, PENTAX 00677964072239 2-8-460 HOOKUP, ASSY WOLF 4K 00677964092756 2-8-511 ASSY, HOOK-UP, OLY 00677964066726 2-8-513 ASSY HOOKUP OLY 4K ESOPHA 00677964102394 2-8-522 ASSY, FUJINON 4K-JET 40677964025387 2-8-523 ASSY, HKUP, FUJI 4K SER 5 00677964074158 2-8-526 ASSY, HOOKUP FUJI 4K+JET 00677964071904 2-8-527 ASSY, FUJI 700 NO FWJ 00677964111648 2-8-528 HOOK, EI-580BT 40677964025394 2-8-534 ASSY, HOOK-UP, PEN-4K+JET 00677964073632 2-8-537 ASSY, HKUP, PTX90 4K+JET 00677964068492 2-8-539 HOOK, PTX I20 FWJ 40677964039827 2-8-540 ASSY-HOOK-UP,STORZ,5K 00677964091223 2-8-611 ASSY, HOOK-UP, OLY 00677964066719 2-8-612 ASSY, HOOKUP, PENTAX 00677964073571 2-8-614 ASM HU OLY TGF-UC180J 00677964101984 2-8-617 ASSY, HKUP, OLY 2 BIOPSY 00677964073427 2-8-623 ASSY,HKUP,FUJI-5 4K+JET 00677964091476 2-8-625 ASSY, HOOKUP, EG-580UT 00677964077678 2-8-626 ASSY, HOOKUP, EG-580UR 00677964077685 2-8-627 ASSY, HKUP, FUJI 700 SER 00677964083006 2-8-634 ASSY, HOOKUP PENTAX DUAL 00677964074189 2-8-639 HOOK, EG3X-J10 40677964006560 2-8-640 ASSY,HOOK-UP STORZ 6K 00677964074417 2-8-711 ASSY, HOOKUP, OLYMPUS 5K 00677964070662 2-8-718 ASSY, HOOKUP, OLY 160/180 00677964070655 2-8-740 ASSY, HOOK-UP, STORZ 00677964102479 2-8-811 ASSY HKUP OLY-ECHO+LIFT 00677964070624 2-8-901 KIT TEE/TOE/RUS HU ADV+ 00677964046926 5-8-010 ASSY, HOOKUP DBL LT 00677964071874 5-8-030 ASSY, HOOKUP 00677964094644 5-8-040 ASSY HOOKUP STORZ 0K DBL 00677964072772 5-8-050 ASSY, HOOKUP, DILATOR 00677964072963 5-8-112 HOOKUP 2-SCOPE 1-K 00677964072307 5-8-190 HOOK DBL, IS, ION 40677964025493 5-8-210 ASSY, HOOKUP 00677964080333 5-8-245 HOOKUP KARLSTORZ-2K 00677964102493 2-8-001HAN HU ZERO CHANNEL NO LT 00677964064739 2-8-002HAN ADVANTAGE TEST BLOCK 00677964046568 2-8-010HAN ASSEMBLY, HOOK-UP,OLYMPUS 00677964001802 2-8-030HAN ASSY,HOOKUP,PENTAX-OK 00677964037399 2-8-112HAN ASSY, HOOK-UP OLYMPUS 1K 00677964001819 2-8-160HAN ASSY, ADV HOOKUP, WOLF 00677964037443 2-8-210HAN ASSY, HOOK-UP OLYMPUS 2K 00677964001826 2-8-213HAN ASSY, HOOKUP, OLYMPUS-2K 00677964001871 2-8-218HAN ASSY HOOKUP OLY 2K 00677964061707 2-8-245HAN ASSY, HOOKUP, STORZ-2K 00677964037511 2-8-330HAN ASSY, HOOK-UP, PENTAX-3K 00677964001970 2-8-334HAN ASSEMBLY, HOOK-UP, PENTAX 00677964001994 2-8-335HAN ASSY,HOOKUP,OLYMPUS 00677964037634 2-8-336HAN ASSY,HKUP FUJI 70 BRONC 00677964045387 2-8-338HAN ASSY, HU, FUJI BRONCH U/S 00677964053443 2-8-421HAN ASSY, HOOKUP, FUJINON 00677964037658 2-8-428CAS HOOK, CAS, ED-580XX 40677964024663 2-8-428HAN HOOK, HAN, ED-580XX 40677964024670 2-8-431CAS ASSY, CASSETTE, PENTAX 00677964002045 2-8-431HAN ASSY, HOOK-UP, PENTAX 00677964002052 2-8-511HAN ASSY, HOOK-UP, OLY 00677964002144 2-8-526HAN ASSY, HOOKUP FUJI 4K+JET 00677964053764 2-8-536HAN HOOKUP,PENTAX,70ULT, 5K 00677964044168 2-8-537CAS ASSY,CASS,PTX 90 4K+JET 00677964037801 2-8-537HAN ASSY HKUP,PTX90 4K+JET 00677964037818 2-8-611HAN ASSY, HOOK-UP, OLY 00677964002236 2-8-626CAS ASSY, CASS, FUJINON 580UR 00677964077661 2-8-627HAN ASSY, HAN, FUJI 700 SER 00677964089701 2-8-634CAS ASSY,CASS PENTAX DUAL CH 00677964054815 2-8-634HAN ASSY,HOOKUP PENTAX DUAL 00677964054808 2-8-640HAN ASSY, HOOK-UP STORZ 6K 00677964087097 2-8-711HAN ASSY, HOOKUP, OLYMPUS-5K 00677964037924 2-8-718HAN ASSY,HOOK-UP, OLY 160/180 00677964064777 2-8-811HAN ASSY HKUP OLY-ECHO W/LIFT 00677964053542 2-8-902H HU BLOCK ULTRASOUND PROBE 00677964061509 5-8-030HAN ASSY, HOOKUP 00677964046681 5-8-050HAN ASSY,HOOKUP, DILATOR 00677964040306 5-8-112HAN ASSY, HOOKUP 2-SCOPE 1-K 00677964051548 5-8-244HAN ASSY, HKUP 2K DBL 00677964045165
Recalling Firm/
Manufacturer		 Steris Corporation
5960 Heisley Rd
Mentor OH 44060-1834
For Additional Information Contact
440-392-7601
Manufacturer Reason
for Recall		 Identification label on affected hookups could become illegible over time due to the label's ink coming off. This may potentially prevent users from being able to effectively identify the hookup and may ultimately result in postponement of patient procedures.
FDA Determined
Cause 2		 Process control
Action On November 13, 2023, the firm notified customers via URGENT MEDICAL DEVICE RECALL letters. Customers were instructed to inspect their inventory for affected product. You should not attempt to use a hookup that cannot be effectively identified. Steris will provide either a replacement hookup or replacement label for all affected hookups. If you have questions regarding this matter, please contact Regulatory_Compliance@STERIS.com.
Quantity in Commerce 2545 US; 992 OUS
Distribution Domestic distribution nationwide. Foreign distribution to Australia Canada China Hong Kong Italy Malaysia Netherlands New Zealand Singapore Thailand
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FEB and Original Applicant = Medivators Inc.
510(K)s with Product Code = FEB and Original Applicant = MEDIVATORS REPROCESSING SYSTEMS
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