Craniotomy Pack recall: Sterility Concern
CRANIOTOMY PACK, Pack Number DYNJ46552O
Why was Craniotomy Pack recalled?
A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was placed in the non-sterile portion of certain sterile convenience kits and distributed. In the event that the user assumes sterility during its use, there is an increased risk of patient infection.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI/DI Case 40195327467044, UDI/DI Each 10195327467043; Lot Numbers: 24ADB788, 23LDA936, 23JDB278, 23HDA872
- Product
- CRANIOTOMY PACK, Pack Number DYNJ46552O
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 188 units
- Distribution
- US: TX, IL, CA
- Recall date
- September 18, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)