Epidural Anesthesia Kit
Recall Summary Medline is recalling epidural anesthesia kits (Spine Pack-LF, Kit Number PHS719414B) distributed worldwide because testing found that the neuro sponges in these kits contain higher-than-expected endotoxin levels, meaning they don't meet safety specifications. This recall affects medical facilities and healthcare providers who received these kits.
- Product
- Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPINE PACK-LF, Medline Kit Number/SKU PHS719414B
- Reason
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-03-19
- Status
- Open, Classified
- Distribution
- Worldwide distribution.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/0c2a61c7-9d03-4512-8882-3b60189097f5