Medline Medical Procedure Kits with Neuro Sponges Recalled for Endotoxin
Medline Industries is recalling multiple medical procedure kits containing Medline Neuro Sponges due to higher-than-expected endotoxin levels. The affected kits were distributed worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class II recall of a medical device component (sponges used in high-risk surgical procedures including ventriculoperitoneal shunts, PICC lines, and vascular access procedures). Endotoxin contamination on devices used in sterile surgical procedures poses a risk of infection and harm. No illnesses or injuries are reported in the source text, so the score does not exceed 3 per the rubric.
Plain-English summary
Medline Industries, LP is recalling 3,588 medical procedure kits containing Medline Neuro Sponges distributed worldwide. The kits include 15 different product models with various SKU numbers, including VP SHUNT, PICC LINE PACK, A-V FISTULA PACK, and other surgical procedure kits.
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
Affected lot numbers and kit models are listed in detail on the FDA website. Hospitals and healthcare facilities using these kits should verify their inventory against the specific kit numbers and lot codes provided by the FDA and Medline. Any kits matching the affected lot numbers should not be used.
Healthcare providers with questions or concerns should contact Medline Industries directly for instructions on replacement or return of affected products.
The recalled product
- Product
- Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. VP SHUNT, Medline Kit Number/SKU CDS840193V; 2. SHY VP SHUNT CDS, Medline Kit Number/SKU CDS982389J; 3. VP SHUNT ADULT PACK-LF, Medline Kit Number/SKU DYNJ0117497G; 4. PICC LINE…
- Manufacturer
- Medline Industries, LP
- Hazard
- Affected units
- 3,588
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 CDS840193V: UDI/DI each 10193489822540
- UDI/DI case 40193489822541
- Lot Number : 23JBW804
- Lot Number : 23JBX015
- Lot Number : 23JBD094
- Lot Number : 23IBQ501
- Lot Number : 23FBO564
- Lot Number : 23EBW686
- Lot Number : 23DBO524
- Lot Number : 22GBU281
- Lot Number : 22EBR456
- Lot Number : 22EBM213
- Lot Number : 22EBN031
- Lot Number : 22DBP331
- Lot Number : 22MBA145
- Lot Number : 22ABM907
- Lot Number : 21KBE066
- Lot Number : 21JBE527
- Lot Number : 21HBH244
- Lot Number : 21HBE520
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 31 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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