Utilized Medical is recalling 19,400 of their Python embolectomy catheters, Bard embolectomy catheters, and OTW Latis cleansing catheters as a result of the catheter tip might detach throughout use.
If this occurs, items of the catheter might break off within the affected person’s physique, probably resulting in critical hurt together with surgical procedure to take away the tip, harm to the blood vessel, or demise, the recall discover notes.
The US Meals and Drug Administration (FDA) has recognized this as a Class 1 recall, essentially the most critical type, due to the potential for critical damage or demise.
Since 2015, there have been 46 complaints relating to this downside. The FDA has obtained three medical system studies however no studies of demise or damage.
The Python and Bard embolectomy catheters and the OTW Latis cleansing catheters are latex balloon catheters used for short-term blockage, closing of a blood vessel, or infusion of fluids.
The recalled catheters have been made between July 23, 2015, and November 8, 2018, and distributed between August 25, 2015, and March 1, 2019.
Python embolectomy catheters
A4E01, A4E02, A4E03, A4E04, A4E05, A4E06, A4E08, A4E09
Bard embolectomy catheters
CE0340DR, CE0380DR, CE0440DR,CE0480DR CE0540DR, CE0580DR, CE0680DR
OTW Latis cleansing catheters
Utilized Medical has despatched an “pressing” medical system recall letter to all affected prospects advising them to test their stock for the recalled product and full a recall notification affirmation kind to acknowledge the recall and point out if any recalled catheters can be returned.
The recall affirmation discover must be returned to Utilized Medical by e-mail to firstname.lastname@example.org or by fax to 949-713-8908.
For product return questions, prospects could contact Jaclene Rios-Simpson, buyer relations senior supervisor, at 949-713-8688 or email@example.com.
Adversarial reactions or high quality issues associated to this recall must be reported to the FDA’s MedWatch program.
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