Recall Z-0633-2025
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) MAMMOPLASTY-LF, REF CDS983478L; 2) MAMMOPLASTY-LF, REF CDS983478M; 3) PLASTICS FREE FLAP, REF CDS983493M; 4) PLASTIC TORSO-LF, REF CDS983496L; 5) PLASTIC TORSO-LF, REF CDS983496M; 6) PLASTIC HEAD AND NECK-LF, REF CDS983498N; 7) ACH PLASTICS BREAST-LF, REF CDS983639J; 8) ACH PLASTICS BREAST-LF, REF CDS983639K; 9) BREAST ABD, REF CDS984267J; 10) DAY SURG PLASTIC CDS, REF CDS984993N; 11) DAY SURG PLASTIC CDS, REF CDS984993O; 12) DAY SURG PLASTIC CDS, REF CDS984993P; 13) PLASTIC PACK, REF DYNJ00264L; 14) LKLND BRST CHST PK RFID-LF, REF DYNJ0101536L; 15) OCULOPLASTY PACK-LF, REF DYNJ0252232U; 16) PLASTICS PACK, REF DYNJ02615G; 17) BREAST PBM-LF, REF DYNJ0318423M; 18) FLAP RECONSTRUCTION PACK-LF, REF DYNJ0378388P; 19) BREAST PACK-LF, REF DYNJ0378394R; 20) BREAST PACK-LF, REF DYNJ0378394S; 21) BREAST PACK-LF, REF DYNJ0378394T; 22) BREAST ABDOMINOPLASTY MZ PK-LF, REF DYNJ0428947K; 23) BREAST ABDOMINOPLASTY MZ PK-LF, REF DYNJ0428947L; 24) ASC MAJOR PLASTIC PACK-LF, REF DYNJ0854517M; 25) ASC ENT PLASTIC PACK-LF, REF DYNJ0854650J; 26) BREAST PACK-LF, REF DYNJ0956628M; 27) BREAST PACK-LF, REF DYNJ0956628N; 28) BREAST PACK-LF, REF DYNJ0956628O; 29) AUGMENTATION #87-RF, REF DYNJ27319U; 30) AUGMENTATION #87-RF, REF DYNJ27319V; 31) PLASTICS PACK-LF, REF DYNJ36107J; 32) PLASTIC MINOR PACK, REF DYNJ37620F; 33) CHEST/BREAST PACK, REF DYNJ39118C; 34) PLASTIC BREAST PACK, REF DYNJ40620C; 35) PLASTIC BREAST PACK, REF DYNJ40620D; 36) BREAST RECONSTRUCTION-HOULE, REF DYNJ44852M; 37) BREAST MINOR PK RFID, REF DYNJ52409J; 38) BREAST MAJOR PACK, REF DYNJ52435J; 39) BREAST MAJOR PK RFID, REF DYNJ52435K; 40) BREAST PACK, REF DYNJ57527C; 41) TRANSGENDER MASTECTOMY 2, REF DYNJ58257G; 42) BREAST PACK SSC, REF DYNJ59733A; 43) BREAST PACK, REF DYNJ60511B; 44) BREAST PACK, REF DYNJ60511F; 45) PLASTIC PACK, REF DYNJ61755B; 46) TYMPANOPLASTY, REF DYNJ63332D; 47) BREAST PACK, REF DYNJ63369D; 48) BREAST SURGERY FOAKS, REF DYNJ63577C; 49) MAJOR PLASTIC FOAKS, REF DYNJ63579C; 50) MAJOR PLASTIC PACK FAIRFAX, REF DYNJ63612C; 51) MAJOR BREAST WOMENS PACK, REF DYNJ63647C; 52) PLASTIC BASIN PACK, REF DYNJ63883B; 53) PLASTICS WOODBURN, REF DYNJ64001B; 54) BREAST PK, REF DYNJ64144B; 55) BREAST PK, REF DYNJ64144C; 56) PACK,PLASTIC, REF DYNJ65477B; 57) PACK,PLASTIC BASIC ASC, REF DYNJ65485A; 58) OSC BREAST PACK, REF DYNJ65808A; 59) CHEST/BREAST PACK, REF DYNJ66495A; 60) PLASTICS PACK, REF DYNJ66610B; 61) BREAST PACK, REF DYNJ66739B; 62) MAJOR PLASTICS PACK, REF DYNJ67968A; 63) BREAST PACK, REF DYNJ68464A; 64) FLAP PACK, REF DYNJ80179A; 65) PLASTICS PACK, REF DYNJ81797A; 66) PLASTICS PACK, REF DYNJ81811A; 67) MINOR PLASTICS PACK, REF DYNJ82196; 68) MINOR PLASTICS PACK, REF DYNJ82196A; 69) DELNOR MAJOR PLASTICS PACK, REF DYNJ82248; 70) DELNOR SIMPLE PLASTIC PACK, REF DYNJ82250; 71) DELNOR SIMPLE PLASTIC PACK, REF DYNJ82250A; 72) DELNOR AUGMENTATION PACK, REF DYNJ82265; 73) DELNOR AUGMENTATION PACK, REF DYNJ82265A; 74) AUGMENTATION PACK, REF DYNJ82279; 75) AUGMENTATION PACK, REF DYNJ82279A; 76) PLASTIC SURGERY PACK, REF DYNJ82352; 77) PLASTIC SURGERY PACK, REF DYNJ82352A; 78) FREE FLAP 2 PACK, REF DYNJ82659B; 79) FREE FLAP 1 PACK, REF DYNJ82660A; 80) FREE FLAP 1 PACK, REF DYNJ82660B; 81) FACE PACK, REF DYNJ83532; 82) BREAST RECONSTRUCTION PACK-LF, REF DYNJ83612A; 83) PLASTIC PACK, REF DYNJ83856; 84) BREAST PACK, REF DYNJ84332; 85) MAJOR PLASTIC PACK, REF DYNJ84827; 86) PLASTICS PACK, REF DYNJ84966; 87) PLASTIC PACK, REF DYNJ85702; 88) FACIAL PLASTICS FLAP PACK, REF DYNJ86031; 89) BREAST-CHEST, REF DYNJ900294K; 90) GENERAL PLASTIC-LF, REF DYNJ901738O; 91) TRAM RECONSTRUCTION-LF, REF DYNJ901753L; 92) PLASTIC UNIVERSAL, REF DYNJ901792J; 93) MID HUDSON BREAST, REF DYNJ903614C; 94) MID HUDSON BREAST, REF DYNJ903614D; 95) MID HUDSON BREAST, REF DYNJ903614F; 96) MID HUDSON PLASTICS, REF DYNJ903616F; 97) MID HUDSON PLASTICS, REF DYNJ903616G; 98) MID
Codes / lots: 1) REF CDS983478L, UDI/DI 10195327497286 (each) 40195327497287 (case), Lot Numbers: 23JDA999, 23KDB756, 24ADA957, 24DDA553; 2) REF CDS983478M, UDI/DI 10198459000065 (each) 40198459000066 (case), Lot Numbers: 24EDB504; 3) REF CDS983493M, UDI/DI 10195327497415 (each) 40195327497416 (case), Lot Numbers: 23LDA144, 24ADA328; 4) REF CDS983496L, UDI/DI 10195327497408 (each) 40195327497409 (case), Lot Numbers: 23KDC085, 24ADB601; 5) REF CDS983496M, UDI/DI 10198459000201 (each) 40198459000202 (case), Lot Numbers: 24EDA817; 6) REF CDS983498N, UDI/DI 10198459000188 (each) 40198459000189 (case), Lot Numbers: 24EDA816; 7) REF CDS983639J, UDI/DI 10195327228149 (each) 40195327228140 (case), Lot Numbers: 22IBF012, 22IBF004, 22LBE960, 22KBK687; 8) REF CDS983639K, UDI/DI 10195327351533 (each) 40195327351534 (case), Lot Numbers: 23EBA182, 23EBN996, 23CBV828, 23FBP157, 23FBH151; 9) REF CDS984267J, UDI/DI 10193489288872 (each) 40193489288873 (case), Lot Numbers: 22GBR052, 22FBG539, 22KBU660, 23ABL613, 23DBD827; 10) REF CDS984993N, UDI/DI 10195327031114 (each) 40195327031115 (case), Lot Numbers: 22EBV339; 11) REF CDS984993O, UDI/DI 10195327175764 (each) 40195327175765 (case), Lot Numbers: 22GBF349…
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-0633-2025
- Initiated
- October 9, 2024
- Posted by FDA
- December 5, 2024
- Product code
- FTN – Plastic Surgery And Accessories Kit
- Quantity
- 25877 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-0629-2025 Class II | MEDLINE convenience kits labeled as: 1) ZALE HEAD & NECK CDS, REF CDS983184I; 2) ENT…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-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 |