Capnostream 35 Portable Respiratory Monitor, Product numbers PM35MN02, PM35MN01, PM35MN05, DLPM35MN02 - Product Usage: use during both no motion and motion conditions and for patients who are well or poorly perfused.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Serial numbers: SF16030134 SF16240121 SF16360313 SF16450067 SF17010227 SF17010247 SF17030358 SF17050642 SF17090981 SF17110474 SF17120491 SF17140419 SF17150846 SF17180407 SF17200722 SF17240406 SF18020067 SF18020101 SF18020103 SF18030281 SF18090439 SF18090443 SF18110356 SF18271901 SF18271902 SF18271903 SF18271904 SF18271905 SF18271907 SF18271908 SF18271909 SF18271910 SF18271911 SF18271912 SF18271913 SF18271914 SF18271915 SF18271916 SF18271917 SF18271918 SF18271919 SF18271920 SF18271921 SF18271922 SF18271923 SF18271924 SF18271938 SF18271941 SF18280055 SF18301062 SF18420402 SF18430101 SF18430150 SF18430151 SF18430154 SF18430155 SF18430156 SF18430158 SF18430159 SF18430161 SF18430163 SF18430164 SF18430169 SF18430171 SF18430172 SF18430173 SF18430174 SF18430176 SF18430177 SF18430179 SF18430181 SF18430182 SF18430183 SF18430187 SF18430188 SF18430193 SF18430194 SF18430195 SF18430196 SF18430197 SF19250492 SF19260529 SF19330724 SF19470574 SF19480478 SF19480479 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- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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:
- Covidien Llc
- Reason for Recall:
- The firm has released software update V01.05.02.16 (also known as V1.5.2) in response to customer reports of a false display of the message, "Temperature Exceeds Limits" followed by automatic shutdown of the monitor with no accompanying alarm.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Capnostream 35 Portable Respiratory Monitor, Product numbers PM35MN02, PM35MN01, PM35MN05, DLPM35MN02 - Product Usage: use during both no motion and motion conditions and for patients who are well or poorly perfused.
Product Codes/Lot Numbers:
Serial numbers: SF16030134 SF16240121 SF16360313 SF16450067 SF17010227 SF17010247 SF17030358 SF17050642 SF17090981 SF17110474 SF17120491 SF17140419 SF17150846 SF17180407 SF17200722 SF17240406 SF18020067 SF18020101 SF18020103 SF18030281 SF18090439 SF18090443 SF18110356 SF18271901 SF18271902 SF18271903 SF18271904 SF18271905 SF18271907 SF18271908 SF18271909 SF18271910 SF18271911 SF18271912 SF18271913 SF18271914 SF18271915 SF18271916 SF18271917 SF18271918 SF18271919 SF18271920 SF18271921 SF18271922 SF18271923 SF18271924 SF18271938 SF18271941 SF18280055 SF18301062 SF18420402 SF18430101 SF18430150 SF18430151 SF18430154 SF18430155 SF18430156 SF18430158 SF18430159 SF18430161 SF18430163 SF18430164 SF18430169 SF18430171 SF18430172 SF18430173 SF18430174 SF18430176 SF18430177 SF18430179 SF18430181 SF18430182 SF18430183 SF18430187 SF18430188 SF18430193 SF18430194 SF18430195 SF18430196 SF18430197 SF19250492 SF19260529 SF19330724 SF19470574 SF19480478 SF19480479 SF19480480 SF19480484 SF19480485 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Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0515-2021
Related Recalls
A manufacturing issue could lead to a malformed cover tube press which can lead to internal components' movement during firing - leading to the potential for uncontrolled motion.
A manufacturing issue could lead to a malformed cover tube press which can lead to internal components' movement during firing - leading to the potential for uncontrolled motion.
Bedside SpO2 Patient Monitoring System alarms not heard/recognized, resulting in: treatment delay, lack of low oxygen saturation response, respiratory failure, arrhythmia. Highlighting operator's manual: 1)For patient Safety don't silence/decrease alarm volume, 2)Sensor off alarm (no perfusion detected) is low priority alarm, 3)Set monitors to Homecare Mode outside of hospital/professional setting