Recall Z-0629-2025
MEDLINE INDUSTRIES, LP - Northfield · initiated October 9, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: 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…
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 taken
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.
Details
- Recall number
- Z-0629-2025
- Initiated
- October 9, 2024
- Posted by FDA
- December 5, 2024
- Product code
- OFR – Tracheobronchial Suction Catheter Kit
- Quantity
- 24754 units
- Distribution
- US Nationwide distribution.
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0622-2025 Class II | MEDLINE convenience kits labeled as: 1) TRACH TOTE, REF DYNJ85691; 2) TRACHEOSTOMY, REF…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0623-2025 Class II | MEDLINE medical convenience kits labeled as: 1) ACETABULAR PACK-LF, REF DYNJ0572894I; 2)…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0624-2025 Class II | MEDLINE convenience kits labeled as: 1) ANGIO PACK #2, REFDYNJ39185D; 2) CV MINOR CATH…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0625-2025 Class II | MEDLINE convenience kits labeled as: 1) MAJOR VASCULAR-LF, REF CDS840232L; 2) AVF-LF…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0626-2025 Class II | MEDLINE convenience kits labeled as: 1) CVL PACK, REF DYNJ00281O; 2) VASCULAR ACCESS…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0627-2025 Class II | MEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF, REF DYNJ0160598C; 2)…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0628-2025 Class II | MEDLINE convenience kits labeled as: 1) ORAL SURGERY PK RFID, REF DYNJ52404I; 2) ORL…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0630-2025 Class II | MEDLINE convenience kits labeled as: 2) ABDOMINAL LAPAROSCOPY, REF CDS760057K; 3)…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0631-2025 Class II | MEDLINE convenience kits labeled as: 1) GENERAL ENDOSCOPY PACK, REF DYNJ44673G; 2) ENDO…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0632-2025 Class II | MEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0633-2025 Class II | MEDLINE convenience kits labeled as: 1) MAMMOPLASTY-LF, REF CDS983478L; 2)…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0634-2025 Class II | MEDLINE convenience kits labeled as: 1) LAKELAND SINGLE BASIN PACK-LF, REF DYNJ0619907I…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0635-2025 Class II | Refer to RES or lead review memo for complete list of affected reference/catalog numbersMedline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0636-2025 Class II | MEDLINE convenience kits labeled as: COLON WOUND CLOSURE PACK, REF DYNJ52141BMedline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0637-2025 Class II | MEDLINE convenience kits labeled as: 1) BURN, REF CDS983465M; 2) BURN, REF CDS983465N…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0638-2025 Class II | MEDLINE convenience kits labeled as: 1) CLEAN CLOSING PACK, REF DYNJ80686A; 2) CLEAN…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0639-2025 Class II | MEDLINE convenience kits labeled as: L&D MINOR PACK, REF DYNJ82672Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0640-2025 Class II | MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202P; 2) BASIC NEURO…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0641-2025 Class II | MEDLINE convenience kits labeled as: 1) VAGINAL, REF CDS984955M; 2) DAY SURG LARGE VAG…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0642-2025 Class II | MEDLINE convenience kits labeled as: 1) LITHOTOMY/PELVISCOPY PACK, REF DYNJ0531985R; 2)…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0643-2025 Class II | MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY-LF, REF CDS760059I; 2) GYN…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0644-2025 Class II | MEDLINE convenience kits labeled as: 1) CIRCUMCISION PACK, REF DYNJ16826O; 2)…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0645-2025 Class II | MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075V; 2)…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0646-2025 Class II | MEDLINE convenience kits labeled as: 1) MAJOR LITHOTOMY CDS-LF, REF CDS760056G; 2) LAVH…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0647-2025 Class II | MEDLINE convenience kits labeled as: 1) TOT/ GYN LITHOTOMY CDS, REF CDS985431J; 2) TOT/…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0648-2025 Class II | MEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81, REF DYNJ27466S; 2) EYE PACK…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0649-2025 Class II | MEDLINE convenience kits labeled as: 1) ORTHO LAMINECTOMY-LF, REF CDS780112J; 2) NEURO…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |