FDA Hits Covidien's Peripheral Infusion Systems With Class 1 Recall
Use: The Trellis 6 and Trellis 8 Peripheral Infusion systems are used to treat blood clots that may form in the veins or arteries of the arms, hands, legs, or feet. The systems have two balloons that are inflated to isolate a clot. Medication is released between the balloons to reduce the size of or dissolve the clot so it can be removed. These devices are used by health care providers.
Recall Class: Class I
Date Recall Initiated: December 10, 2014
Manufacturing and distribution dates: 1126 units were distributed in the U.S. from June 6, 2014 to November 13, 2014.
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Reason for Recall: A manufacturing error caused the balloon inflation ports to be mislabeled. This may cause the physician using the device to deflate the balloons in the incorrect order. If this happens, there is a potential for blood clots to dislodge and move into the lungs.
Depending upon the size of these clots, there is the possibility of serious patient injury or death.
Public Contact: Questions about this recall can be directed to Covidien customer service at 1-800-716-6700 between the hours of 7:00 a.m. and 7:00 p.m. CT or email CustomerServiceUS@Covidien.com.
FDA District: Minneapolis District Office
More Information about this Recall:
Customers were sent an urgent product recall letter dated December 15, 2014. The letter identified the affected product and actions for customers.
Customers were instructed to discontinue the use of the Trellis 6 and 8 infusion systems and return it to Covidien along with a response form included in the letter.
Customers with questions should contact their Covidien sales rep or to Covidien Service at 1-800-716-6700.
About Class I Recalls
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.
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