Nicolet¿ Elite¿ 2 MHz OB Probe, Non-Fetal Monitor, Model #: X1L007, Catalog Code: N200. Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, etc.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Serial numbers: CER0179 CER0240 CER0241 CER0242 CER0243 CER0244 CER0245 CER0246 CER0247 CER0248 CER0249 CER0250 CER0251 CER0252 CER0253 CER0254 CER0255 CER0256 CER0257 CER0258 CER0259 CER0260 CER0261 CER0262 CER0263 CER0264 CER0265 CER0266 CER0267 CER0268 CER0269 CER0270 CER0271 CER0272 CER0273 CER0274 CER0275 CER0276 CER0277 CER0278 CER0279 CER0280 CER0281 CER0282 CER0283 CER0284 CER0285 CER0286 CER0287 CER0288 CER0289 CER0290 CER0291 CER0292 CER0293 CER0294 CER0295 CER0296 CER0297 CER0298 CER0299 CER0300 CER0301 CER0302 CER0303 CER0304 CER0305 CER0306 CER0307 CER0308 CER0309 CER0310 CER0311 CER0312 CER0313 CER0314 CER0315 CER0316 CER0317 CER0318 CER0319 CER0320, and CER0321.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Natus Neurology Inc
Reason for Recall:
Some of the Elite 2 and 3 Obstetric probes and 5 MHz Vascular Probes may exhibit excessive background noise that may mask the users ability to clearly hear heart rate and/or blood flow.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Nicolet¿ Elite¿ 2 MHz OB Probe, Non-Fetal Monitor, Model #: X1L007, Catalog Code: N200. Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, etc.

Product Codes/Lot Numbers:

Serial numbers: CER0179 CER0240 CER0241 CER0242 CER0243 CER0244 CER0245 CER0246 CER0247 CER0248 CER0249 CER0250 CER0251 CER0252 CER0253 CER0254 CER0255 CER0256 CER0257 CER0258 CER0259 CER0260 CER0261 CER0262 CER0263 CER0264 CER0265 CER0266 CER0267 CER0268 CER0269 CER0270 CER0271 CER0272 CER0273 CER0274 CER0275 CER0276 CER0277 CER0278 CER0279 CER0280 CER0281 CER0282 CER0283 CER0284 CER0285 CER0286 CER0287 CER0288 CER0289 CER0290 CER0291 CER0292 CER0293 CER0294 CER0295 CER0296 CER0297 CER0298 CER0299 CER0300 CER0301 CER0302 CER0303 CER0304 CER0305 CER0306 CER0307 CER0308 CER0309 CER0310 CER0311 CER0312 CER0313 CER0314 CER0315 CER0316 CER0317 CER0318 CER0319 CER0320, and CER0321.

Distribution:

Nationwide distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2726-2017

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