Medline Medical Procedure Kits with Neuro Sponges Recalled
Medline is recalling multiple medical procedure kits containing Neuro Sponges due to higher-than-expected endotoxin levels that may render the product out-of-specification.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall of medical devices used in critical surgical procedures. The hazard—elevated endotoxin levels—poses a potential risk of serious adverse reactions if the sponges are used in sterile surgical fields, particularly in neurosurgical, cardiovascular, and vascular procedures. Although no injuries or illnesses are reported in the source text, the theoretical risk combined with the Class II classification and the scope of distribution justifies a Severe rating.
Plain-English summary
Medline Industries, LP is recalling Medline medical procedure kits that contain Medline Neuro Sponges. The recall affects 26 different kit models, including OPEN HEART CDS, NEURO VASCULAR PACK-LF, VP SHUNT PACK-LF, and others, totaling approximately 4016 kits distributed worldwide.
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product. This indicates that in-market product may be out-of-specification for endotoxin. Endotoxins are bacterial components that can cause adverse reactions if present at elevated levels in medical devices used in surgical and other critical care procedures.
Healthcare facilities and providers who have received these kits should discontinue use and contact Medline for instructions on return or replacement. Specific lot numbers and SKU identifiers for all affected kits have been identified and are available through Medline. Customers should verify their inventory against the provided list of affected lot numbers before using any remaining stock.
The recalled product
- Product
- Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. OPEN HEART CDS PART A, Medline Kit Number/SKU CDS840402AI; 2. OPEN HEART CDS, Medline Kit Number/SKU CDS984890V; 3. RR-NEURO VASCULAR PACK-LF, Medline Kit Number/SKU DYNJ0394874L; 4.
- Manufacturer
- Medline Industries, LP
- Hazard
- endotoxin
- contamination
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Medline Kit Number/SKU CDS840402AI: UDI/DI each 10195327334024
- UDI/DI case 40195327334025
- Lot Number: 23JLA668
- Lot Number: 23JLA240
- Medline Kit Number/SKU CDS984890V: UDI/DI each 10198459374364
- UDI/DI case 40198459374365
- Lot Number: 25IMG470
- Lot Number: 25GMI158
- Lot Number: 25GMC404
- Medline Kit Number/SKU DYNJ0394874L: UDI/DI each 10193489800005
- UDI/DI case 40193489800006
- Lot Number: 23ILA647
- Lot Number: 23HLA953
- Lot Number: 23GLA064
- Lot Number: 23ELA715
- Lot Number: 22KLB111
- Lot Number: 22GLB222
- Lot Number: 22ELA384
- Lot Number: 22ELA314
- Lot Number: 22CLA246
Distribution
Distribution scope not specified by the agency.