Wingman35 Crossing Catheter Recall [US]


US FlagUS/Silver Spring: Wingman 35 Crossing Catheter Recall [US]ReFlow Medical recalls an estimated 2327 Wingman35 Crossing Catheters due to suspected tip splitting and consequential risks of injury, internal laceration and bacterial infection, all serious health hazards. FDA: http://ht.ly/UdCY30bCptV

Direct link: https://www.fda.gov/Safety/Recalls/ucm556525.htm

Additional information:
The US Food and Drug Administration (“FDA”) reports the following Catheters are subject to this recall:

  • Wingman35 Crossing Catheters

==> No barcodes, UPCs, DINs, item numbers or other identification numbers were listed with this recall notification.

According to the FDA, certain Wingman35 Crossing Catheters have been found to exhibit tip splitting or separation, which has resulted in two (2) adverse events. ReFlow has received two (2) complaints of Catheter-Tip splitting and/or separation.

The Wingman Crossing Catheters in this recall were distributed between March 2015 and March 2017.

==> Never depend on your senses of sight, smell, taste or touch to confirm food poisoning, adulteration or contamination. If in doubt about the safety of any food, return it to your retailer for refund or toss it out in your household garbage, making sure neither small children nor household pets can access the suspect food.

If you believe you have purchased or have in your possession any of the recalled Catheters, please do not use them. Instead, return the Catheters to the store or online outlet where you purchased them for a full refund.

If you have any questions about this recall, please contact ReFlow Medical Customer Relations at 1-949-481-0399 from 8:00 AM to 4:30 PM Pacific Standard Time or by e-mail at info@reflowmedical.com.

==> To see other recalls and notifications regarding medical equipment, please search for “medical” using the Search Box at the top of this page.

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More information about this recall:
Recalls Direct RIN: 8655-2017
Want to read more about this recall?
==> Please click on the links above to visit the originating site.
Want to read more about other recalls?
==> Please click on the links below.

General information:
More recalls? Back to the main Recalls Direct page:
==> http://www.RecallsDirect.com/
About the Recalls Direct service:
==> http://wp.me/P2bVty-2
Visit the Living Safely site:
==> http://www.LivingSafely.org/
Report an unsafe food or drug you purchased in the US [external: new window opens]:
==> http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm095859.htm
Search for a recalled food or drug on the US FDA Web archive [external: new window opens]:
==> http://www.fda.gov/Safety/Recalls/ArchiveRecalls/default.htm

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E. & O. E.

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