The Natus Cranial Access Kit is designed to be a recall
The Natus Cranial Access Kit is designed to be a complete, single use and disposable accessory and instrumentation set that is used to create an…
Why was The Natus Cranial Access Kit is designed to be a recalled?
Due to Cranial Access Kits containing recalled sterile surgical drapes. The sterile surgical drapes are being recalled due to the liner on the adhesive component is difficult to remove without damaging the product and may render the product unusable.
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?
Part Number: HITH1 UDI-DI Code: 382830048590 Lot Number: 22GDB675 Part Number: HITHNDRZR UDI-DI Code: 382830048620 Lot Number: 22HDA557 Part Number: HITHLT UDI-DI Code: 382830048637 Lot Number: 22IDB724
- Product
- The Natus Cranial Access Kit is designed to be a complete, single use and disposable accessory and instrumentation set that is used to create an…
- Recalling firm
- Natus Medical Incorporated
- Quantity
- 249 kits
- Distribution
- U.S. Nationwide distribution in the states of AK, CA, CT, DC, FL, GA, IA, ID, IL, KS , MD, MI, MT, ND, NE, NJ, NV, NY, OH, OR, TX, and WA.
- Recall date
- December 28, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)