The Recall Desk
HighFDA (Devices)·Z-0735-2023·Announced 2022-12-28

Natus Cranial Access Kit Recalled Due to Defective Sterile Surgical Drapes

Natus Medical is recalling 249 Cranial Access Kits distributed nationwide. The sterile surgical drape liners are difficult to remove without damage, potentially rendering the kits unusable for neurosurgical procedures.

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 an FDA Class II medical device recall with no reported illnesses or injuries. The hazard—a defective drape liner that may render the surgical kit unusable—poses a risk of harm to patients requiring critical neurosurgical procedures, but impact has not yet been clinically documented.

Plain-English summary

Natus Medical Incorporated is recalling the Cranial Access Kit, a single-use, disposable instrumentation set used to create intracranial burr-holes for procedures such as ventriculostomy and intracranial pressure (ICP) monitoring. The recall involves 249 kits with part numbers HITH1 (Lot 22GDB675), HITHNDRZR (Lot 22HDA557), and HITHLT (Lot 22IDB724).

The kits are being recalled because they contain sterile surgical drapes with a defective liner on the adhesive component. The liner is difficult to remove without damaging the product, and this damage may render the kit unusable for its intended surgical application.

The affected kits were distributed nationwide to hospitals and surgical centers in 22 states: Alaska, California, Connecticut, Washington D.C., Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Maryland, Michigan, Montana, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oregon, Texas, and Washington.

If you have received one of these Cranial Access Kits, contact Natus Medical Incorporated immediately to determine if your kit is affected. Do not use the recalled kits until you have verified they are not part of this recall. Report any adverse events to the FDA MedWatch program.

The recalled product

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 intracranial burr-hole typically required for procedures such as ventriculostomy or intracranial pressure (ICP) monitoring. The various
Manufacturer
Natus Medical Incorporated
Category
Medical Device — Neurosurgical Instrumentation
Hazard
  • product-defect
  • device-malfunction

Distribution

Distributed nationwide across the United States.

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