Medline Medical Procedure Kits Recalled for High Endotoxin Levels
Medline is recalling certain medical procedure kits containing neuro sponges because they may have higher-than-expected endotoxin levels, indicating out-of-specification product in the market.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall involving a sterile surgical product (neuro sponges used in neurological procedures) with a high-risk hazard (endotoxin contamination). Although no adverse events have been reported, endotoxin on sterile surgical products poses a direct risk of serious adverse health consequences including infection and inflammation during invasive procedures.
Plain-English summary
Medline Industries, LP is recalling certain Medline medical procedure kits containing Medline Neuro Sponges. During an internal review, Medline identified higher-than-expected endotoxin levels on a representative neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
The recalled kits were distributed worldwide. The specific kit numbers (CDS780045N, CDS780045O, CDS780046O, CDS780089AB, CDS780089AC, CDS780089W, CDS780089X, CDS780089Y, CDS780102K, CDS780102M, CDS780102N, CDS780105L, CDS780105M, CDS780105N, CDS780105P, CDS780109P, CDS780109R, CDS780109S, CDS780111N, CDS780111O, CDS780111P, CDS780111R, CDS780112I, CDS780112J, CDS780119V, CDS780165L, CDS780165M, CDS780165N, CDS780165O, CDS780165Q, CDS780165R, CDS780165S, CDS780165T, CDS780165U, CDS780166Q, CDS780166R, CDS780166S, CDS780166T, CDS780166U, CDS780166V, CDS780166W, CDS780166X, CDS780204Q, CDS780205Q, CDS780205R, CDS780205S, CDS780206R, CDS780206T, and CDS780208I) with multiple lot numbers are affected. Healthcare facilities and providers who received these kits should discontinue use and contact Medline for further instructions regarding return or replacement.
No adverse events have been reported to date related to this issue.
The recalled product
- Product
- Medline medical procedure kits, containing Medline Neuro Sponges (4077 in total), LAMINECTOMY, CRANI, etc.
- Manufacturer
- Medline Industries, LP
- Hazard
- endotoxin
- sterility-risk
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 CDS780045N: UDI/DI each 10193489355406
- UDI/DI case 40193489355407
- Lot Number: 23CBR748
- Lot Number: 22LBP661
- Lot Number: 22JBI816
- Lot Number: 22JBI817
- Lot Number: 22GBG444
- Lot Number: 22GBG445
- Lot Number: 22FBM376
- Lot Number: 22DBB694
- Lot Number: 22DBA187
- Lot Number: 21LBP574
- Lot Number: 21JBU289
- Lot Number: 21FBS507
- Lot Number: 21FBL891
- Lot Number: 21BBF167
- Medline Kit Number/SKU CDS780045O: UDI/DI each 10195327362638
- UDI/DI case 40195327362639
- Lot Number: 23FBU385
- Lot Number: 23EBT969
Distribution
Distribution scope not specified by the agency.
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