Sterile Surgical Kit Contains Non-Sterile Component Without Label
A non-sterile Mastisol component was included in certain sterile craniotomy packs without proper labeling. If users assume the component is sterile, it could increase infection risk during surgery.
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 kit with a non-sterile, mislabeled component that creates a risk of patient infection during a critical surgical procedure. No illnesses or injuries have been reported, placing it at the High severity level for risk-of-harm products without reported injury.
Plain-English summary
Medline Industries is recalling certain CRANIOTOMY PACK kits (Pack Number DYNJ46552O) containing a non-sterile Mastisol component that was placed in the sterile portion of the kits without being labeled as non-sterile. A total of 188 units were distributed in Texas, Illinois, and California.
The recall affects surgical teams and healthcare providers using these kits. If a user assumes the Mastisol component is sterile during use, there is an increased risk of patient infection. The affected lot numbers are 24ADB788, 23LDA936, 23JDB278, and 23HDA872.
Healthcare facilities that received these kits should identify and quarantine affected units and verify proper labeling before use. Users should contact Medline Industries or consult the FDA recall notice for return instructions and additional guidance.
The recalled product
- Product
- CRANIOTOMY PACK, Pack Number DYNJ46552O
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- contamination
- infection-risk
- mis-labeling
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 (6)
- UDI/DI Case 40195327467044
- UDI/DI Each 10195327467043
- Lot Numbers: 24ADB788
- 23LDA936
- 23JDB278
- 23HDA872
Distribution
Distributed in 3 states:
- CA
- IL
- TX
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