Class 2 Device Recall Medline

• Date Initiated by Firm: October 09, 2024
• Date Posted: December 05, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0629-2025
• Recall Event ID: 95621
• Product Classification: Tracheobronchial suction catheter kit - Product Code OFR
• Product: MEDLINE convenience kits labeled as: 1) ZALE HEAD & NECK CDS, REF CDS983184I; 2) ENT MINOR, REF CDS983466L; 3) EAR, REF CDS983486K; 4) HEAD AND NECK, REF CDS984259N; 5) HEAD AND NECK, REF CDS984259O; 6) HEAD & NECK CDS, REF CDS984282L; 7) T & A, REF CDS984895I; 8) T & A, REF CDS984895J; 9) T&A, REF CDS984895K; 10) HEAD NECK PACK-LF, REF DYNJ0101206D; 11) HEAD NECK PACK-LF, REF DYNJ0101206F; 12) MAJOR EAR PACK-LF, REF DYNJ0101314D; 13) NILES T A PACK, REF DYNJ0101397M; 14) NILES T A PACK RFID, REF DYNJ0101397N; 15) THYROID PACK-LF, REF DYNJ0131777I; 16) THYROID PACK-LF, REF DYNJ0131777J; 17) THYROID PACK-LF, REF DYNJ0131777K; 18) THYROID PACK-LF, REF DYNJ0131777L; 19) MINOR ENT HARPER PACK-LF, REF DYNJ0160700F; 20) MAJOR ENT HARPER PACK-LF, REF DYNJ0161710G; 21) MAJOR ENT HARPER PACK-LF, REF DYNJ0161710I; 22) T&A PACK, REF DYNJ02462L; 23) ENT/HEAD & NECK PACK, REF DYNJ02463J; 24) ENT BASIC PACK-LF, REF DYNJ0387711F; 25) MAJOR ENT MZ PACK-LF, REF DYNJ0429404O; 26) MAJOR ENT PACK-LF, REF DYNJ0451506P; 27) EAR PACK-LF, REF DYNJ0774664K; 28) MAJOR HEAD/NECK PACK-LF, REF DYNJ0826705N; 29) TRANSPHENOIDAL PACK-LF, REF DYNJ0843898I; 30) MINOR HEAD & NECK #40-RF, REF DYNJ21948S; 31) NASALPLASTY #61-RF, REF DYNJ27320V; 32) DB ENT CSTM PACK-LF, REF DYNJ33585F; 33) ENT RECONSTRUCTION PK, REF DYNJ37531G; 34) BEC MOHS PACK, REF DYNJ43111G; 35) SVMMC HEAD AND NECK PACK, REF DYNJ43776G; 36) TONSIL PACK, REF DYNJ44170G; 37) T AND A PACK, REF DYNJ44982J; 38) MAJOR ENT PACK, REF DYNJ45576B; 39) MAJOR ENT PACK, REF DYNJ48370C; 40) HEAD & NECK PACK, REF DYNJ52419J; 41) HEAD & NECK PK-RFID, REF DYNJ52419K; 42) BL THYROID PK RFID- LF, REF DYNJ52426J; 43) HEAD & NECK PACK, REF DYNJ52758G; 44) THYROID PACK, REF DYNJ53648B; 45) SMH HEAD & NECK PACK, REF DYNJ56995C; 46) CHRISTUS SR HEAD AND NECK PACK, REF DYNJ60922F; 47) HEAD&NECK PACK, REF DYNJ61309B; 48) MHPB HEAD AND NECK PACK, REF DYNJ62032B; 49) SMH THYROID PACK, REF DYNJ62649A; 50) TRANSSPHENOIDAL, REF DYNJ63315B; 51) TYMPANOPLASTY, REF DYNJ63332F; 52) AFCH TONSIL, REF DYNJ63333B; 53) AFCH TONSIL, REF DYNJ63333C; 54) TAC THYROIDECTOMY PACK, REF DYNJ63334C; 55) TAC THYROIDECTOMY PACK, REF DYNJ63334D; 56) HEAD NECK PACK IP, REF DYNJ63336B; 57) HEAD NECK PACK IP, REF DYNJ63336C; 58) THYROID TRAY FFX, REF DYNJ63625C; 59) ENT DRAPE PACK, REF DYNJ63890A; 60) HEAD AND NECK, REF DYNJ64235B; 61) PACK,HEAD AND NECK, REF DYNJ65487B; 62) PEDI ENT PACK, REF DYNJ67401B; 63) ACH HEAD & NECK PACK-LF, REF DYNJ67754B; 64) OSC HEAD AND NECK PACK, REF DYNJ67985B; 65) OSC HEAD AND NECK PACK, REF DYNJ67985C; 66) ENT HEAD NECK PACK, REF DYNJ68211B; 67) ENT BASIC PACK-LF, REF DYNJ69587B; 68) EAR PACK, REF DYNJ82172; 69) ENT MINOR PACK, REF DYNJ82175; 70) ENT MINOR PACK, REF DYNJ82175B; 71) FACIAL PACK, REF DYNJ82177; 72) FACIAL PACK, REF DYNJ82177B; 73) MEDIASTINOSCOPY PACK, REF DYNJ82194; 74) EAR ENT PACK, REF DYNJ82285; 75) HEAD AND NECK PACK, REF DYNJ82654A; 76) HEAD AND NECK PACK, REF DYNJ82654B; 77) GENERAL EAR PACK, REF DYNJ82656C; 78) T AND A PACK, REF DYNJ82657A; 79) T AND A PACK, REF DYNJ82657B; 80) ORAL NASAL, REF DYNJ901073G; 81) ORAL NASAL, REF DYNJ901073I; 82) EAR-LF, REF DYNJ901801K; 83) T&A, REF DYNJ902116I; 84) ENT RESECTION, REF DYNJ902126I; 85) OMFS, REF DYNJ902258J; 86) THYROID, REF DYNJ902508I; 87) HEAD AND NECK, REF DYNJ903810C; 88) TRIPOINT HEAD AND NECK, REF DYNJ904491J; 89) TRIPOINT HEAD AND NECK, REF DYNJ904491K; 90) PLASTIC CRANIOPLASTY-LF, REF DYNJ904558F; 91) CW T&A SINUS, REF DYNJ906052B; 92) HEAD&NECK, REF DYNJ906655F; 93) HEAD&NECK, REF DYNJ906655G; 94) PACK,COCHLEAR IMPLANT, REF DYNJ906901A; 95) HEAD&NECK, REF DYNJ906948B; 96) HEAD&NECK, REF DYNJ906948C; 97) WMC COCHLEAR IMPLANT ADD ON, REF DYNJ907206F; 98) PLASTIC ENT, REF DYNJ907393C; 99) PLASTIC ENT, REF DYNJ907393D; 100) PLASTIC ENT - NTSC, REF DYNJ907411A; 101) ENT-LF, REF DYNJ907577; 102) MINOR ENT # 56653-LF, REF DYNJVB91072
• Code Information: 1) REF CDS983184I, UDI/DI 10195327178352 (each) 40195327178353 (case), Lot Numbers: 22LBB795, 23FBJ754, 23BBH106, 23CBT619, 23HBY087, 23HBP974, 23KBI669, 23LBD939, 23KBM394; 2) REF CDS983466L, UDI/DI 10195327497217 (each) 40195327497218 (case), Lot Numbers: 23JDB850, 23IDB539, 23KDB596, 24DDB278, 24DDA871, 24BDA878, 24ADA819, 24CDB315; 3) REF CDS983486K, UDI/DI 10195327497200 (each) 40195327497201 (case), Lot Numbers: 23JDA349, 24CDA873, 24ADA731, 24ADB821; 4) REF CDS984259N, UDI/DI 10193489862232 (each) 40193489862233 (case), Lot Numbers: 22KBJ788, 22JBH993, 22JBH284, 22LBB413; 5) REF CDS984259O, UDI/DI 10195327297817 (each) 40195327297818 (case), Lot Numbers: 23ABM783, 23ABK571; 6) REF CDS984282L, UDI/DI 10195327438920 (each) 40195327438921 (case), Lot Numbers: 23LMA461; 7) REF CDS984895I, UDI/DI 10193489983814 (each) 40193489983815 (case), Lot Numbers: 22FBL382, 22KBD792, 23DBM334, 23ABM451, 23FBK273; 8) REF CDS984895J, UDI/DI 10195327469092 (each) 40195327469093 (case), Lot Numbers: 23KBH104, 23KBH045; 9) REF CDS984895K, UDI/DI 10195327620875 (each) 40195327620876 (case), Lot Numbers: 24BBQ203, 24CBM385; 10) REF DYNJ0101206D, UDI/DI 10195327028855 (each) 40195327028856 (case), Lot Numbers: 22EMG943, 22GMB620; 11) REF DYNJ0101206F, UDI/DI 10195327269470 (each) 40195327269471 (case), Lot Numbers: 22KMB120, 22KMB121, 23EMB091, 23DMB727, 23BMD165, 23FMD066, 23GMH580, 23JMA281, 23KBV062, 24ABN126, 24DBT379, 24DBD204; 12) REF DYNJ0101314D, UDI/DI 10195327286453 (each) 40195327286454 (case), Lot Numbers: 23HDA133, 23FDA245; 13) REF DYNJ0101397M, UDI/DI 10195327295813 (each) 40195327295814 (case), Lot Numbers: 22LBL740; 14) REF DYNJ0101397N, UDI/DI 10195327332952 (each) 40195327332953 (case), Lot Numbers: 23ABU509, 23FBJ127, 23CBT405, 23IBK582; 15) REF DYNJ0131777I, UDI/DI 10195327124755 (each) 40195327124756 (case), Lot Numbers: 22FMH017; 16) REF DYNJ0131777J, UDI/DI 10195327216627 (each) 40195327216628 (case), Lot Numbers: 22GMH364; 17) REF DYNJ0131777K, UDI/DI 10195327248031 (each) 40195327248032 (case), Lot Numbers: 23BMC153, 22JMF782, 22LMB801, 23CME007; 18) REF DYNJ0131777L, UDI/DI 10195327416065 (each) 40195327416066 (case), Lot Numbers: 23IMA466, 23GMI881, 23IMG022, 23LMA388, 23KMB800, 23FMI119, 24AMI064, 24CMA472; 19) REF DYNJ0160700F, UDI/DI 10195327304294 (each) 40195327304295 (case), Lot Numbers: 22LDC085, 23DDB405; 20) REF DYNJ0161710G, UDI/DI 10195327304300 (each) 40195327304301 (case), Lot Numbers: 23BDA563, 23ADB489; 21) REF DYNJ0161710I, UDI/DI 10195327375003 (each) 40195327375004 (case), Lot Numbers: 23DDB344, 23DDA346; 22) REF DYNJ02462L, UDI/DI 10195327269975 (each) 40195327269976 (case), Lot Numbers: 23HMB171; 23) REF DYNJ02463J, UDI/DI 10195327291112 (each) 40195327291113 (case), Lot Numbers: 23IMI445, 23JMJ897; 24) REF DYNJ0387711F, UDI/DI 10198459005893 (each) 40198459005894 (case), Lot Numbers: 24FMI719; 25) REF DYNJ0429404O, UDI/DI 10195327050092 (each) 40195327050093 (case), Lot Numbers: 22EMH911, 22HMD262, 22KMD325, 23CMH759, 23CMC034; 26) REF DYNJ0451506P, UDI/DI 10195327046033 (each) 40195327046034 (case), Lot Numbers: 22FBD904, 22IBG229, 22KBJ001, 22KBF361, 22FBJ383, 23CBA965, 23CBC262, 23HBP907, 23FBJ832, 23KBJ579, 23IBW132; 27) REF DYNJ0774664K, UDI/DI 10195327045999 (each) 40195327045990 (case), Lot Numbers: 23FBV288, 23FBD634, 23IBP555; 28) REF DYNJ0826705N, UDI/DI 10193489265682 (each) 40193489265683 (case), Lot Numbers: 22GMA868, 23EMI243, 23KMJ016; 29) REF DYNJ0843898I, UDI/DI 10195327288693 (each) 40195327288694 (case), Lot Numbers: 23DDB257, 23ADB839, 23GDA828, 23IDC126; 30) REF DYNJ21948S, UDI/DI 10195327104726 (each) 40195327104727 (case), Lot Numbers: 22JBB180, 22JBC021; 31) REF DYNJ27320V, UDI/DI 10195327104719 (each) 40195327104710 (case), Lot Numbers: 22DBE423, 22DBS049, 22JBH705, 22DBB586, 23EBE794, 22LBQ654, 22DBS054, 23CBL338, 23FBO863; 32) REF DYNJ33585F, UDI/DI 10195327469528 (each) 40195327469529 (case), Lot Numbers: 23HDB160, 23JDA407; 33) REF DYNJ37531G, UDI/DI 10195327497224 (each) 40195327497225 (case), Lot Numbers: 23IDC199, 24DDA059; 34) REF DYNJ43111G, UDI/DI 10195327007614 (each) 40195327007615 (case), Lot Numbers: 22EBK964, 22DBM378, 23ABD640, 22JBK014, 23FBR570, 23GBW466, 23JBS323, 23KBV859, 24BBA668, 24CBH236; 35) REF DYNJ43776G, UDI/DI 10193489989717 (each) 40193489989718 (case), Lot Numbers: 22GBK302, 22JBD640, 23BBA747, 23GBN842, 22JBG530, 23GBS093, 23JBT523, 24ABR379, 24CBD054, 24EBE400; 36) REF DYNJ44170G, UDI/DI 10195327413040 (each) 40195327413041 (case), Lot Numbers: 23KBF904; 37) REF DYNJ44982J, UDI/DI 10195327381080 (each) 40195327381081 (case), Lot Numbers: 23HBH626, 23FBE306; 38) REF DYNJ45576B, UDI/DI 10195327059200 (each) 40195327059201 (case), Lot Numbers: 23DBJ589, 23DBB974, 22JBD150, 22IBS180, 23GBP473, 23IBI793, 23JBS988, 23GBA243, 23FBF257; 39) REF DYNJ48370C, UDI/DI 10195327491635 (each) 40195327491636 (case), Lot Numbers: 23IBK589, 23JBH535; 40) REF DYNJ52419J, UDI/DI 10195327222703 (each) 40195327222704 (case), Lot Numbers: 22HDB178; 41) REF DYNJ52419K, UDI/DI 10195327339265 (each) 40195327339266 (case), Lot Numbers: 23DDB020, 23BDC171, 23HDB272, 23FDC083; 42) REF DYNJ52426J, UDI/DI 10195327339333 (each) 40195327339334 (case), Lot Numbers: 23DDB127, 23HDB256, 23FDA419; 43) REF DYNJ52758G, UDI/DI 10195327409685 (each) 40195327409686 (case), Lot Numbers: 23HBE646, 23EBU553, 23JBE363; 44) REF DYNJ53648B, UDI/DI 10195327012083 (each) 40195327012084 (case), Lot Numbers: 22GBH903, 23GBQ991, 24DBT986, 23ABJ120, 23EBB251, 23GBS479; 45) REF DYNJ56995C, UDI/DI 10195327103415 (each) 40195327103416 (case), Lot Numbers: 22EBQ045, 22GBM277; 46) REF DYNJ60922F, UDI/DI 10195327470265 (each) 40195327470266 (case), Lot Numbers: 23IBK275; 47) REF DYNJ61309B, UDI/DI 10195327155735 (each) 40195327155736 (case), Lot Numbers: 22EMC922, 22LMD294, 23JBV869; 48) REF DYNJ62032B, UDI/DI 10195327058289 (each) 40195327058280 (case), Lot Numbers: 22FBP870, 22KBG692, 23BBD433, 23EBR621, 23IBK599, 23GBM365; 49) REF DYNJ62649A, UDI/DI 10195327109912 (each) 40195327109913 (case), Lot Numbers: 22GDA925, 22EDB879, 22KDB262, 22JDA165, 22KDB900; 50) REF DYNJ63315B, UDI/DI 10193489958102 (each) 40193489958103 (case), Lot Numbers: 22FBY596, 22FBR138; 51) REF DYNJ63332F, UDI/DI 10195327270773 (each) 40195327270774 (case), Lot Numbers: 23HMF316; 52) REF DYNJ63333B, UDI/DI 10193489986877 (each) 40193489986878 (case), Lot Numbers: 22EBV290, 22DBV017; 53) REF DYNJ63333C, UDI/DI 10195327270018 (each) 40195327270019 (case), Lot Numbers: 23GMC984, 23AMI108, 23FMG683, 23IMG360; 54) REF DYNJ63334C, UDI/DI 10195327041243 (each) 40195327041244 (case), Lot Numbers: 22DBN552; 55) REF DYNJ63334D, UDI/DI 10195327275679 (each) 40195327275670 (case), Lot Numbers: 22LME564, 23BMB162, 23HMF139, 23JMG131; 56) REF DYNJ63336B, UDI/DI 10193489943740 (each) 40193489943741 (case), Lot Numbers: 22FBR970; 57) REF DYNJ63336C, UDI/DI 10195327273422 (each) 40195327273423 (case), Lot Numbers: 23AMA553, 23IMG718, 23HMF616, 23KMF634, 23JMA204, 23IMD286; 58) REF DYNJ63625C, UDI/DI 10195327350390 (each) 40195327350391 (case), Lot Numbers: 23CBT772, 23JBA948, 23EBU585, 23IBB697, 23JBO841; 59) REF DYNJ63890A, UDI/DI 10195327221843 (each) 40195327221844 (case), Lot Numbers: 22JDC115, 23GDB230, 23BDA782, 23JDB416, 23KDB075, 23CDC581, 23IDA389, 24DDB748; 60) REF DYNJ64235B, UDI/DI 10193489382662 (each) 40193489382663 (case), Lot Numbers: 22GMI068, 23CMD690; 61) REF DYNJ65487B, UDI/DI 10195327303662 (each) 40195327303663 (case), Lot Numbers: 23ABN443, 23CBM523, 23IBM894; 62) REF DYNJ67401B, UDI/DI 10195327353001 (each) 40195327353002 (case), Lot Numbers: 23CMG483, 23DMD152, 23KMH872; 63) REF DYNJ67754B, UDI/DI 10195327227982 (each) 40195327227983 (case), Lot Numbers: 22HBR985, 22HBT613, 22JBX075, 22LBJ260, 23BBS826, 23DBC526; 64) REF DYNJ67985B, UDI/DI 10195327022679 (each) 40195327022670 (case), Lot Numbers: 22EMG226; 65) REF DYNJ67985C, UDI/DI 10195327270407 (each) 40195327270408 (case), Lot Numbers: 23KMJ096; 66) REF DYNJ68211B, UDI/DI 10195327352493 (each) 40195327352494 (case), Lot Numbers: 23FMF614; 67) REF DYNJ69587B, UDI/DI 10195327372354 (each) 40195327372355 (case), Lot Numbers: 23HMC907, 24DMA249; 68) REF DYNJ82172, UDI/DI 10195327182601 (each) 40195327182602 (case), Lot Numbers: 23FDA365; 69) REF DYNJ82175, UDI/DI 10195327182618 (each) 40195327182619 (case), Lot Numbers: 23HDB289; 70) REF DYNJ82175B, UDI/DI 10195327534929 (each) 40195327534920 (case), Lot Numbers: 23JMG205; 71) REF DYNJ82177, UDI/DI 10195327182656 (each) 40195327182657 (case), Lot Numbers: 23FDC242; 72) REF DYNJ82177B, UDI/DI 10195327534936 (each) 40195327534937 (case), Lot Numbers: 23KMC523; 73) REF DYNJ82194, UDI/DI 10195327183486 (each) 40195327183487 (case), Lot Numbers: 23FDC244; 74) REF DYNJ82285, UDI/DI 10195327179045 (each) 40195327179046 (case), Lot Numbers: 23IMC659; 75) REF DYNJ82654A, UDI/DI 10195327489649 (each) 40195327489640 (case), Lot Numbers: 23KBF180, 23IBU511, 23HBT084; 76) REF DYNJ82654B, UDI/DI 10195327557690 (each) 40195327557691 (case), Lot Numbers: 23LBJ944, 24ABW630, 24DBT628, 24CBV286; 77) REF DYNJ82656C, UDI/DI 10195327489656 (each) 40195327489657 (case), Lot Numbers: 23IBR904; 78) REF DYNJ82657A, UDI/DI 10195327489663 (each) 40195327489664 (case), Lot Numbers: 23IBS673; 79) REF DYNJ82657B, UDI/DI 10195327557782 (each) 40195327557783 (case), Lot Numbers: 24ABK113, 24BBP749, 24DBF082, 24DBQ952; 80) REF DYNJ901073G, UDI/DI 10193489944600 (each) 40193489944601 (case), Lot Numbers: 22EMH483, 22IMF369, 22HMI055, 22HMC726, 22GMI088, 22GME976, 22KMA663, 22IMF609, 22GMB443; 81) REF DYNJ901073I, UDI/DI 10195327232504 (each) 40195327232505 (case), Lot Numbers: 22KMC464, 23BMB966, 23AMF537, 23AME484; 82) REF DYNJ901801K, UDI/DI 10195327495534 (each) 40195327495535 (case), Lot Numbers: 24CDA462, 23JDC094, 24ADA394; 83) REF DYNJ902116I, UDI/DI 10195327497422 (each) 40195327497423 (case), Lot Numbers: 23JDB483, 23KDB475, 24ADA959, 24CDB867; 84) REF DYNJ902126I, UDI/DI 10195327497231 (each) 40195327497232 (case), Lot Numbers: 23LDA136, 24BDB428, 24ADA164; 85) REF DYNJ902258J, UDI/DI 10195327497477 (each) 40195327497478 (case), Lot Numbers: 24ADA255, 24ADA820, 24BDB764; 86) REF DYNJ902508I, UDI/DI 10195327336677 (each) 40195327336678 (case), Lot Numbers: 23EBR103; 87) REF DYNJ903810C, UDI/DI 10193489274134 (each) 40193489274135 (case), Lot Numbers: 22JBR487, 23IBG239, 23HBO191, 23KBC866, 23EBP263, 24ABA510, 24BBV513, 24BBE242; 88) REF DYNJ904491J, UDI/DI 10195327157517 (each) 40195327157518 (case), Lot Numbers: 22EBU208; 89) REF DYNJ904491K, UDI/DI 10195327186333 (each) 40195327186334 (case), Lot Numbers: 23ABV356; 90) REF DYNJ904558F, UDI/DI 10195327497378 (each) 40195327497379 (case), Lot Numbers: 24DDC043; 91) REF DYNJ906052B, UDI/DI 10195327010164 (each) 40195327010165 (case), Lot Numbers: 22IBA880, 23CBG753, 23BBL154, 23DBF038; 92) REF DYNJ906655F, UDI/DI 10193489993998 (each) 40193489993999 (case), Lot Numbers: 22JDC012, 22IDB318, 22GDB705, 22LDA295; 93) REF DYNJ906655G, UDI/DI 10195327301835 (each) 40195327301836 (case), Lot Numbers: 23GDB026, 23HDC613, 23EDB087, 23FDA004; 94) REF DYNJ906901A, UDI/DI 10195327303358 (each) 40195327303359 (case), Lot Numbers: 23ABE779, 23FBP600, 23HBS841; 95) REF DYNJ906948B, UDI/DI 10195327380991 (each) 40195327380992 (case), Lot Numbers: 23EBD951, 23LBE795, 23HBI581, 23EBN930, 23HBY101, 23GBS824; 96) REF DYNJ906948C, UDI/DI 10195327567156 (each) 40195327567157 (case), Lot Numbers: 24ABQ831, 24CBD478, 24DBD740, 24DBN334; 97) REF DYNJ907206F, UDI/DI 10195327600907 (each) 40195327600908 (case), Lot Numbers: 24BBL775, 24DBM144; 98) REF DYNJ907393C, UDI/DI 10195327359133 (each) 40195327359134 (case), Lot Numbers: 23EMD891; 99) REF DYNJ907393D, UDI/DI 10195327462345 (each) 40195327462346 (case), Lot Numbers: 23IMG307; 100) REF DYNJ907411A, UDI/DI 10195327335748 (each) 40195327335749 (case), Lot Numbers: 23GMC938; 101) REF DYNJ907577, UDI/DI 10193489437713 (each) 40193489437714 (case), Lot Numbers: 22GBH331, 22HBS399, 23IBO496, 23CBW088; 102) REF DYNJVB91072, UDI/DI 10193489801156 (each) 40193489801157 (case), Lot Numbers: 22ILA262, 22HLA486
• Recalling Firm/ Manufacturer: MEDLINE INDUSTRIES, LP - Northfield ; 3 Lakes Dr; Northfield IL 60093-2753
• For Additional Information Contact: Haley Barclay; 866-359-1704
• Manufacturer Reason for Recall: Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
• FDA Determined Cause: Under Investigation by firm
• Action: 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.
• Quantity in Commerce: 24754 units
• Distribution: US Nationwide distribution.
• 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.