Recall Z-0793-2025
MEDLINE INDUSTRIES, LP - Northfield · initiated November 21, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Medline custom medical procedure kits labeled as: 1) CERVICAL PACK-LF, REF DYNJ0867145G; 2) CERVICAL SPINE PACK HUM-LF, REF DYNJ35184F; 3) ANTERIOR CERVICAL-CORPECTOMY, REF DYNJ904827.
Codes / lots: 1) REF DYNJ0867145G, UDI/DI 10889942625413 (EA) 40889942625414 (CS), Lot Numbers: 19BDA435, 19DDD135; 2) REF DYNJ35184F, UDI/DI 10889942567737 (EA) 40889942567738 (CS), Lot Numbers: 19CBC965, 19QBC217; 3) REF DYNJ904827, UDI/DI 10889942743742 (EA) 40889942743743 (CS), Lot Numbers: 19DBD844, 19HBO089, 19HBQ573, 19IBQ930, 19SBE329.
Reason for recall
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
FDA-determined cause: Nonconforming Material/Component
Action taken
Medline issued a MEDICAL DEVICE VOLUNTARY RECALL notice on 11/21/2024 to its consignees via US Mail and email. The notice explained the issue, potential risk to health, and requested that the affected product be quarantined. Once the response is received, Medline will provide labels to place on affected inventory, with instructions for the consignee to remove the affected component prior to using the kit.
Details
- Recall number
- Z-0793-2025
- Initiated
- November 21, 2024
- Posted by FDA
- December 30, 2024
- Product code
- OKV – Obstetrical Kit
- Quantity
- 182 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of UAE, and Canada.
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0777-2025 Class II | Medline custom medical procedure kits labeled as: 1) CATH LAB PACK-LF, REF DYNJ0382559M…Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical… | 11/21/2024Open, Classified |
| Z-0778-2025 Class II | Medline custom medical procedure kits labeled as: 1) OPEN HEART CDS-LF, REFCDS840451M…Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical… | 11/21/2024Open, Classified |
| Z-0779-2025 Class II | Medline custom medical procedure kits labeled as: 1) VP SHUNT CDS, REF CDS983470D; 2)…Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical… | 11/21/2024Open, Classified |
| Z-0780-2025 Class II | Medline custom medical procedure kits labeled as: 1) UMC DR. BAKER SUPPLEMENT, REF…Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical… | 11/21/2024Open, Classified |
| Z-0781-2025 Class II | Medline custom medical procedure kits labeled as: 1) NASAL PACK, REF DYNJ67789A.Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical… | 11/21/2024Open, Classified |
| Z-0782-2025 Class II | See DocManCustom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical… | 11/21/2024Open, Classified |
| Z-0783-2025 Class II | Medline custom medical procedure kits labeled as: 1) FREE FLAP BASIC SET-UP PK, REF…Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical… | 11/21/2024Open, Classified |
| Z-0784-2025 Class II | Medline custom medical procedure kits labeled as: 1) ENDOSCOPIC SKULL BASE, REF…Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical… | 11/21/2024Open, Classified |
| Z-0785-2025 Class II | Medline custom medical procedure kits labeled as: 1) PANENDOSCOPY-LF, REF DYNJ36728C; 2)…Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical… | 11/21/2024Open, Classified |
| Z-0786-2025 Class II | Medline custom medical procedure kits labeled as: 1) MEM MAXILLOFACIAL PACK-LF, REF…Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical… | 11/21/2024Open, Classified |
| Z-0787-2025 Class II | Medline custom medical procedure kits labeled as: 1) NEURO BASIN PACK-LF, REF…Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical… | 11/21/2024Open, Classified |
| Z-0788-2025 Class II | See DocManCustom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical… | 11/21/2024Open, Classified |
| Z-0789-2025 Class II | Medline custom medical procedure kits labeled as: 1) MICRODISECTOMY PACK, REF…Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical… | 11/21/2024Open, Classified |
| Z-0790-2025 Class II | See DocManCustom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical… | 11/21/2024Open, Classified |
| Z-0791-2025 Class II | Medline custom medical procedure kits labeled as: DEEP BRAIN STIMULATION PACK-LFCustom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical… | 11/21/2024Open, Classified |
| Z-0792-2025 Class II | Medline custom medical procedure kits labeled as: 1) ENSEMBLE RACHIS-LF, REF DYNJ47568B…Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical… | 11/21/2024Open, Classified |
| Z-0794-2025 Class II | Medline custom medical procedure kits labeled as: 1) CRANI, REF CDS780089V; 2)…Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical… | 11/21/2024Open, Classified |