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Terminated

Newport HT50 Ventilator. Model No. HT50-H, HT50-HB, HT50-H1, and HT50-H1B. The device is intended to provide continuous or intermittent mechanical ventilator support for the care of individuals who require mechanical ventilation. Specifically, the NEWPORT HT50 is applicable for adult and pediatric (i.e. infant, child and adolescent) patients, greater than or equal to 10 kg (22 Ibs)

FDA Recall Z-2382-2011 · Posted 2011-05-26

Recall StatusTerminated
Product CodeCBK
Date Initiated2010-05-14
Date Terminated2011-06-01
Product Quantity1,113 EP cases

Reason for Recall

The recall was initiated because Newport Medical has confirmed that the Newport HT50 hard shell Emergency Preparedness (EP) Storage Cases must be relabeled to caution users to follow current labeling guidelines for charging the battery for 8 hours but not longer than 24 hours at any one time.

Firm Action

Newport Medical sent an FIELD CORRECTION NOTICE to all affected customers dated May 14, 2010. The letter identified the product, the problem and the action needed to be taken by the customer. Newport Medical also provided a revised labeling for the Emergency Preparedness (EP) Storage Case and an instruction sheet describing where to apply the new labels. Customers were instructed with the information that all the EP storage cases must be relabeled to caution users to follow current labeling guidelines for charging the battery for 8 hours but not longer than 24 hours at any one time. Customers were instructed to complete the attached acknowledgement form and fax it to " [email protected] " Customers with any questions should call Technical Support Department at (800) 451-3111 for US customers, and (714)427-5811 x500 for international customers.

Root Cause

Other

Distribution Pattern

Worldwide Distribution -- USA including states of PA, TX, AK, GA, CA, MD, KY, FL, VA, LA, NC, OK and countries of Canada, Colombia, Armenia and Japan.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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