—#210810

Product

MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY-LF, REF CDS760059I; 2) GYN LAPAROSCOPY CDS #34-RF, REF CDS920099S; 3) GYN MAJOR, REF CDS980998L; 4) ROBOTIC PROCEDURE, REF CDS982128P; 5) ROBOTIC, REF CDS984262N; 6) GYN LAPAROSCOPY, REF CDS984900M; 7) GYN LAPAROSCOPY, REF CDS984900N; 8) DAVINCI PACK-LF, REF DYNJ0101304G; 9) PROSTATE ROBOTIC PACK, REF DYNJ0347372J; 10) URO GYN PACK-LF, REF DYNJ17454N; 11) DB DAVINCI ROBOT PACK-LF, REF DYNJ33592I; 12) ROBOTIC UROLOGY-RF, REF DYNJ38844N; 13) TLH PACK, REF DYNJ42792D; 14) SVMMC GEN ROBOTIC PACK, REF DYNJ43770L; 15) SVMMC ROBOTIC KIDNEY PACK, REF DYNJ43778L; 16) SVMMC GYN ROBOTIC PACK, REF DYNJ43782K; 17) SVMMC ROBOTIC PROSTATE PACK, REF DYNJ43862J; 18) DA VINCI HYSTERECTOMY, REF DYNJ44863O; 19) DA VINCI PROSTATE/COLPOPEXY, REF DYNJ44864S; 20) LAP-GYN PACK, REF DYNJ44876L; 21) LAP-GYN PACK, REF DYNJ44876M; 22) ROBOT PACK, REF DYNJ45184F; 23) GYN ROBOTIC PACK, REF DYNJ47766Q; 24) ST. ANNE'S MULTI PORT PACK, REF DYNJ48638G; 25) RBTC COLON/KIDNEY PK RFID-LF, REF DYNJ52397M; 26) GYN LAP PACK, REF DYNJ52524C; 27) ROBOTIC PACK, REF DYNJ53650D; 28) LAPAROTOMY PACK, REF DYNJ59079D; 29) ROBOTIC GYN PACK, REF DYNJ62107B; 30) GYN UROL BASIC LAPAROSCOPY, REF DYNJ63326D; 31) FAIRFAX DAVINCI TRAY, REF DYNJ63606C; 32) GYN LAP PACK, REF DYNJ64234B; 33) ROBOT GYN SHARED, REF DYNJ64793A; 34) ROBOT GYN SHARED, REF DYNJ64793B; 35) ROBOT GYN SHARED, REF DYNJ64793C; 36) GYN DAVINCI PACK, REF DYNJ65373A; 37) ROBOT PACK, REF DYNJ67190C; 38) TUBAL LIGATION PACK, REF DYNJ68563A; 39) TUBAL LIGATION PACK, REF DYNJ68563B; 40) DAVINCI GYN PACK, REF DYNJ69169A; 41) GYN LAPAROSCOPY PACK, REF DYNJ69490C; 42) ROBOTIC PACK, REF DYNJ84776A; 43) ROBOTIC LAVH, REF DYNJ901281G; 44) ROBOTIC LAP CHOLE, REF DYNJ901282J; 45) GYN LAPAROTOMY, REF DYNJ902498J; 46) WMC ROBOTIC BASE-LF, REF DYNJ902583M; 47) HHI ROBOTIC CDS, REF DYNJ902953G; 48) HHI ROBOTIC CDS, REF DYNJ902953I; 49) HHI ROBOTIC CDS, REF DYNJ902953J; 50) HHI ROBOTIC CDS, REF DYNJ902953K; 51) ROBOTIC GYN & GU, REF DYNJ903459F; 52) SM DAVINCI, REF DYNJ903539G; 53) WEST GYN LAPAROSCOPY, REF DYNJ904490I; 54) ROBOTIC GYN, REF DYNJ904792C; 55) ROBOTIC GENERAL, REF DYNJ904793B; 56) ROBOT, REF DYNJ906112B; 57) ROBOTIC URO LH, REF DYNJ906445A; 58) ROBOTIC URO LH, REF DYNJ906445B; 59) ROBOTIC URO LH, REF DYNJ906445C; 60) WMC THORACIC ROBOTIC, REF DYNJ907153C; 61) DAVINCI, REF DYNJ907392A; 62) DAVINCI, REF DYNJ907392B; 63) DAVINCI ROBOTICS-HERNIA, REF DYNJ907396B; 64) DAVINCI ROBOTICS-HERNIA, REF DYNJ907396C; 65) GYN LAPAROSCOPY - NTSC, REF DYNJ907407A; 66) GYN LAPAROSCOPY - NTSC, REF DYNJ907407B; 67) ROBOTIC-LF, REF DYNJ907910; 68) ROBOTIC-LF, REF DYNJ907910A; 69) GU DAVINCI KIT, REF DYNJ908783; 70) GU DAVINCI KIT, REF DYNJ908783A; 71) GU DAVINCI PACK - LF, REF DYNJ909398A; 72) GYN LAPAROSCOPY, REF DYNJ910084; 73) MHPB GYN ROBOTIC PACK, REF DYNJ910125;

FDA product code: OHD — Gynecological Laparoscopic Kit
Device class: Class 2
Medical specialty: Obstetrics/Gynecology
Affected lot / code info: 85OHD, 1) REF CDS760059I, UDI/DI 10195327009526 (each) 40195327009527 (case), Lot Numbers: 22KBT168, 22GBJ110, 22FBO228, 22FBN206, 23ABM526; 2) REF CDS920099S, UDI/DI 10195327140656 (each) 40195327140657 (case), Lot Numbers: 22EBA153, 23HBS831, 23GBT006, 23ABF835, 23ABE852, 23ABC459, 22IBE827, 22GBP098; 3) REF CDS980998L, UDI/DI 10193489232837 (each) 40193489232838 (case), Lot Numbers: 23HBS764, 24CBA346, 24BBO669; 4) REF CDS982128P, UDI/DI 10195327491659 (each) 40195327491650 (case), Lot Numbers: 23JBV057; 5) REF CDS984262N, UDI/DI 10195327241735 (each) 40195327241736 (case), Lot Numbers: 23ABN752, 23ABH001, 23CBU637, 23EBG216, 23FBL899; 6) REF CDS984900M, UDI/DI 10195327265670 (each) 40195327265671 (case), Lot Numbers: 23EBA735; 7) REF CDS984900N, UDI/DI 10195327448417 (each) 40195327448418 (case), Lot Numbers: 23JBT539, 24ABT539; 8) REF DYNJ0101304G, UDI/DI 10195327351663 (each) 40195327351664 (case), Lot Numbers: 23GDA822, 23CDA336; 9) REF DYNJ0347372J, UDI/DI 10195327555245 (each) 40195327555246 (case), Lot Numbers: 24CBN143, 24DBI923; 10) REF DYNJ17454N, UDI/DI 10195327491604 (each) 40195327491605 (case), Lot Numbers: 23JBR958; 11) REF DYNJ33592I, UDI/DI 10195327469559 (each) 40195327469550 (case), Lot Numbers: 23IDC293; 12) REF DYNJ38844N, UDI/DI 10195327243166 (each) 40195327243167 (case), Lot Numbers: 23DBB947, 23CBN366, 23EBW814, 23BBD619, 23DBI585; 13) REF DYNJ42792D, UDI/DI 10195327653514 (each) 40195327653515 (case), Lot Numbers: 24CBA980; 14) REF DYNJ43770L, UDI/DI 10193489989991 (each) 40193489989992 (case), Lot Numbers: 22IBC524, 22JBT938, 23GBN441, 23KBE916, 23JBJ792, 24ABW049, 24BBJ418, 23DBB305, 22LBI806, 22LBI807, 23ABM291, 23EBT683, 23DBM687, 24CBK840, 24CBA672; 15) REF DYNJ43778L, UDI/DI 10193489990133 (each) 40193489990134 (case), Lot Numbers: 22EBR178, 22DBI437, 22GBK246, 23BBG028, 23FBD832, 23DBB308, 23GBN442, 23LBN691, 24BBK830; 16) REF DYNJ43782K, UDI/DI 10193489989892 (each) 40193489989893 (case), Lot Numbers: 22GBK022, 22JBM498, 22IBD372, 22KBO079, 23JBN680, 23KBK083, 24BBM541, 24ABN836, 24EBE613; 17) REF DYNJ43862J, UDI/DI 10193489990157 (each) 40193489990158 (case), Lot Numbers: 22LLA203, 22JLB142, 22ILA238, 22KLA975, 23ALA636, 23DLA332, 23BLA068, 23FLA225, 23HLA685, 23GLB210, 23KLA370, 23GLA459, 24BLA720, 24ALA170, 23JLA444, 23ILA920, 24DLA220; 18) REF DYNJ44863O, UDI/DI 10195327127619 (each) 40195327127610 (case), Lot Numbers: 22HDB157; 19) REF DYNJ44864S, UDI/DI 10195327127626 (each) 40195327127627 (case), Lot Numbers: 22GBA089, 23DBR620, 22HBY159, 22EBC670, 23BBV092; 20) REF DYNJ44876L, UDI/DI 10195327127695 (each) 40195327127696 (case), Lot Numbers: 22HDB217; 21) REF DYNJ44876M, UDI/DI 10195327298418 (each) 40195327298419 (case), Lot Numbers: 22LDB769, 23CDA215, 23CDA612; 22) REF DYNJ45184F, UDI/DI 10195327191474 (each) 40195327191475 (case), Lot Numbers: 22FBW406, 22JBD483, 23BBK976, 23CBT915; 23) REF DYNJ47766Q, UDI/DI 10195327270001 (each) 40195327270002 (case), Lot Numbers: 23GDA728; 24) REF DYNJ48638G, UDI/DI 10195327109158 (each) 40195327109159 (case), Lot Numbers: 22DBQ919, 23DBB019, 23CBH108, 23ABL241, 23GBM672; 25) REF DYNJ52397M, UDI/DI 10195327339098 (each) 40195327339099 (case), Lot Numbers: 23EDC260; 26) REF DYNJ52524C, UDI/DI 10889942796915 (each) 40889942796916 (case), Lot Numbers: 23CMF377; 27) REF DYNJ53650D, UDI/DI 10195327337643 (each) 40195327337644 (case), Lot Numbers: 23GBT276, 23IBU040, 24ABC282, 24BBH893, 23FBR552, 23IBA185; 28) REF DYNJ59079D, UDI/DI 10195327200251 (each) 40195327200252 (case), Lot Numbers: 22LBL494, 22GBY139, 23ABL800, 23ABB585, 23CBV720, 23JBT579, 23IBM532; 29) REF DYNJ62107B, UDI/DI 10195327350895 (each) 40195327350896 (case), Lot Numbers: 23FBE253; 30) REF DYNJ63326D, UDI/DI 10195327094409 (each) 40195327094400 (case), Lot Numbers: 22JMC433, 22JMC435, 22DBM777; 31) REF DYNJ63606C, UDI/DI 10193489900248 (each) 40193489900249 (case), Lot Numbers: 22FBV006, 23BBC458, 23FBF843, 23JBP024; 32) REF DYNJ64234B, UDI/DI 10193489382655 (each) 40193489382656 (case), Lot Numbers: 22GMB743, 22LMF980; 33) REF DYNJ64793A, UDI/DI 10193489457391 (each) 40193489457392 (case), Lot Numbers: 22GDA994; 34) REF DYNJ64793B, UDI/DI 10195327217914 (each) 40195327217915 (case), Lot Numbers: 23IDA919, 23LDB556, 23ADB401, 22KDB707, 23CDC139, 23CDA142; 35) REF DYNJ64793C, UDI/DI 10195327639075 (each) 40195327639076 (case), Lot Numbers: 24CDA102; 36) REF DYNJ65373A, UDI/DI 10195327417987 (each) 40195327417988 (case), Lot Numbers: 23FMD177; 37) REF DYNJ67190C, UDI/DI 10195327304201 (each) 40195327304202 (case), Lot Numbers: 23BBC622, 22LBO811, 23BBM118, 23DBK217; 38) REF DYNJ68563A, UDI/DI 10193489994841 (each) 40193489994842 (case), Lot Numbers: 23GBW287; 39) REF DYNJ68563B, UDI/DI 10195327511791 (each) 40195327511792 (case), Lot Numbers: 24ABC442, 24ABP074; 40) REF DYNJ69169A, UDI/DI 10195327156480 (each) 40195327156481 (case), Lot Numbers: 23AME723, 23AMA205; 41) REF DYNJ69490C, UDI/DI 10195327243913 (each) 40195327243914 (case), Lot Numbers: 23GDA238; 42) REF DYNJ84776A, UDI/DI 10195327615987 (each) 40195327615988 (case), Lot Numbers: 24DME593, 24BMG248, 24BMB085, 24CMC391, 24CMK067; 43) REF DYNJ901281G, UDI/DI 10195327349066 (each) 40195327349067 (case), Lot Numbers: 23GBU141; 44) REF DYNJ901282J, UDI/DI 10195327349202 (each) 40195327349203 (case), Lot Numbers: 23GBF221, 23GBF801, 23JBU677; 45) REF DYNJ902498J, UDI/DI 10195327336424 (each) 40195327336425 (case), Lot Numbers: 23GBJ197, 23FBK861; 46) REF DYNJ902583M, UDI/DI 10195327600952 (each) 40195327600953 (case), Lot Numbers: 24BBU793; 47) REF DYNJ902953G, UDI/DI 10195327118075 (each) 40195327118076 (case), Lot Numbers: 22HMA128; 48) REF DYNJ902953I, UDI/DI 10195327216597 (each) 40195327216598 (case), Lot Numbers: 22JMC312; 49) REF DYNJ902953J, UDI/DI 10195327296254 (each) 40195327296255 (case), Lot Numbers: 22LMA416, 23AMA855, 23CMB170; 50) REF DYNJ902953K, UDI/DI 10195327488710 (each) 40195327488711 (case), Lot Numbers: 23HMG988, 24AMA644, 23LMA536, 23IMD748, 24DMK165, 24CMH773, 24BMF820, 23IMD761, 24EMG520, 24EMB536, 24FMJ241; 51) REF DYNJ903459F, UDI/DI 10195327200374 (each) 40195327200375 (case), Lot Numbers: 22KBR937, 23EBG039, 23BBK004, 23FBT549, 23HBV186, 23IBC012; 52) REF DYNJ903539G, UDI/DI 10195327425524 (each) 40195327425525 (case), Lot Numbers: 23GMB348; 53) REF DYNJ904490I, UDI/DI 10195327186326 (each) 40195327186327 (case), Lot Numbers: 23ABJ533; 54) REF DYNJ904792C, UDI/DI 10195327072803 (each) 40195327072804 (case), Lot Numbers: 23HDC090, 23CDB391; 55) REF DYNJ904793B, UDI/DI 10195327072650 (each) 40195327072651 (case), Lot Numbers: 22GDA529, 23GDB165, 23HDA865, 23JDC274; 56) REF DYNJ906112B, UDI/DI 10195327597375 (each) 40195327597376 (case), Lot Numbers: 24BBH136, 24DBT158, 24DBV357; 57) REF DYNJ906445A, UDI/DI 10195327167288 (each) 40195327167289 (case), Lot Numbers: 22GBJ176; 58) REF DYNJ906445B, UDI/DI 10195327228392 (each) 40195327228393 (case), Lot Numbers: 23EBT765, 23EBF127; 59) REF DYNJ906445C, UDI/DI 10195327436414 (each) 40195327436415 (case), Lot Numbers: 23JBM489, 23HBV246, 23JBW647, 24BBK908, 24BBQ096, 24DBL767; 60) REF DYNJ907153C, UDI/DI 10195327600778 (each) 40195327600779 (case), Lot Numbers: 24GBT128, 24EBE754; 61) REF DYNJ907392A, UDI/DI 10195327329525 (each) 40195327329526 (case), Lot Numbers: 23CMA009, 23FMI177, 23CMB744, 23GMC935; 62) REF DYNJ907392B, UDI/DI 10195327462338 (each) 40195327462339 (case), Lot Numbers: 23JMC266; 63) REF DYNJ907396B, UDI/DI 10195327329532 (each) 40195327329533 (case), Lot Numbers: 23DMA650, 23BME717, 23BME738, 23GMC937, 23FMC911, 23GMH664, 23FMA674; 64) REF DYNJ907396C, UDI/DI 10195327462352 (each) 40195327462353 (case), Lot Numbers: 23IMF381, 23JME981; 65) REF DYNJ907407A, UDI/DI 10195327335809 (each) 40195327335800 (case), Lot Numbers: 23EME041; 66) REF DYNJ907407B, UDI/DI 10195327462208 (each) 40195327462209 (case), Lot Numbers: 23HMF546; 67) REF DYNJ907910, UDI/DI 10193489941807 (each) 40193489941808 (case), Lot Numbers: 22EBI105, 22IBM319, 22EBG580, 22EBE690, 22EBF759; 68) REF DYNJ907910A, UDI/DI 10195327225155 (each) 40195327225156 (case), Lot Numbers: 23CBN033, 22KBT244; 69) REF DYNJ908783, UDI/DI 10195327183301 (each) 40195327183302 (case), Lot Numbers: 23CDB746, 23FDB402, 23DDC292, 23HDC431; 70) REF DYNJ908783A, UDI/DI 10195327520267 (each) 40195327520268 (case), Lot Numbers: 23KMF011, 23LMC664; 71) REF DYNJ909398A, UDI/DI 10195327338190 (each) 40195327338191 (case), Lot Numbers: 23HME512, 23KME175, 23JMB528, 23HMI269, 24EMC327, 24HMG886; 72) REF DYNJ910084, UDI/DI 10195327568993 (each) 40195327568994 (case), Lot Numbers: 24ABI431, 23LBT816, 24EBD996; 73) REF DYNJ910125, UDI/DI 10195327594930 (each) 40195327594931 (case), Lot Numbers: 24DBF506

Why it was recalled

Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Medline issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 10/11/2024 via mail and email. The notice explained the problem with the Stryker component, potential risk, requested the kits be quarantined pending additional labeling and o respond through their portal: https://recalls.medline.com. Once the response is received, Medline will provide additional labeling to be applied to the affected kits which states the following: "Attention: R-24-219, This kit contains a recalled item, STRYKER SafeAir Smoke Evacuation Pencil, VPN: 0703-047-000, 0703-047-001, 0703-047-002, 0703-046-000, 0703-046-001, 0703-046-002. DO NOT USE THIS COMPONENT. The rest of the kit may be used. Please remove this item only and replace with product from supply. *Do not cover or remove this sticker*". Those further distributing the product were directed to notify their customers.

Recalling firm

Firm: MEDLINE INDUSTRIES, LP Northfield
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2024-10-09
Posted by FDA: 2024-12-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #210810. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.