Ethicon Endo-Surgery Circular Stapler Sets Class I Recall

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Ethicon Endo-Surgery Circular Stapler Sets: Class I Recall – User Difficulty With Firing Stapler Devices

  • Ethicon PROXIMATE HCS Hemorrhoidal Circular Stapler and Accessories 33mm (Product Code: PPH01) 
  • Ethicon PROXIMATE PPH Hemorrhoidal Circular Stapler and Accessories 33mm (Product Code: PPH03)
  • Ethicon TRANSTAR Circular Stapler Procedure Set (Product Code: STR10)

AUDIENCE: Risk Manager, Surgery

ISSUE: FDA notified healthcare professionals of a Class I Recall of these products because of difficulty users have firing the stapler devices, resulting in incomplete firing stroke and incomplete staple formation.

Failure to complete the firing stroke of the stapler can result in severe pain, sphincter dysfunction, rectal wall damage, sepsis, bleeding, and occlusion of the rectal canal. Failure to complete the firing stroke can also result in poor staple formation, dehiscence of the rectal wall staple line and bleeding.

The affected products were manufactured from April 16, 2011 to July 24, 2012 and distributed from April 18, 2011 to July 23, 2012. This recall includes all lots manufactured between April 16, 2011 to July 24, 2012. 
 
BACKGROUND: These devices are used in the surgical treatment of prolapse and hemorrhoids, or in other applications where circular or semicircular stapling of anorectal tissue is needed.

RECOMMENDATION: Customers who have purchased the affected devices will be notified by letter through overnight delivery from Federal Express or UPS. All customers should respond to the included Business Reply Form indicating whether they have the affected devices, quantity of affected devices and if they have or will return the product(s).

Read the MedWatch safety alert, including a link to the Class I recall, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm325965.htm

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