Recall Z-0623-2025
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 medical convenience kits labeled as: 1) ACETABULAR PACK-LF, REF DYNJ0572894I; 2) LOCAL BASIC, REF DYNJ34418L; 3) LOCAL BASIC, REF DYNJ34418M; 4) MINI LOCAL, REF DYNJ900287D
Codes / lots: 1) REF DYNJ0572894I, UDI/DI 10195327045975 (each) 40195327045976 (case), Lot Numbers: 22EBV549, 22FBV442, 23ABU908, 22LBG711, 23CBJ089, 23BBM090, 23GBS959, 23JBG841; 2) REF DYNJ34418L, UDI/DI 10193489969276 (each) 40193489969277 (case), Lot Numbers: 23CBT026, 23ABO601; 3) REF DYNJ34418M, UDI/DI 10195327384371 (each) 40195327384372 (case), Lot Numbers: 23GBA504; 4) REF DYNJ900287D, UDI/DI 10193489798289 (each) 40193489798280 (case), Lot Numbers: 23BBT640, 23FBF622, 23GBL588, 23FBV779, 23EBF038,
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-0623-2025
- Initiated
- October 9, 2024
- Posted by FDA
- December 5, 2024
- Product code
- OFT – Spinal Epidural Anesthesia Kit
- Quantity
- 182 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-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-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 |