Reported Oct 24, 2012 · Terminated
Hemorrhoidal Circular Stapler and Accessories 33mm Product Usage: The PROXIMATE HCS Hemorrhoidal Circular Staplers,…
Ethicon Endo-Surgery Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ethicon Endo-Surgery Inc · 4545 Creek Rd · Cincinnati, OH · 45242-2803
Is this the product you have?
- Hemorrhoidal Circular Stapler
- and Accessories 33mm Product UsageThe PROXIMATE HCS Hemorrhoidal Circular Staplers, (PPH01 and PPH03), and accessories have application for general surgical treatment of anorectal wall defects by means of transanal stapling and resection of mucosal and musculo mucosal tissue. The TRANSTARTM CIRCULAR STAPLER, (STR10), and accessories have application for general surgical treatment of anorectal wall defects by means of transanal stapling and resection of mucosal and musculomucosal tissue
- Lot codes and dates
- PPH01
68 lots19030 piecesExpiration date April 2016 -June 2017
- PPH03
494 lots144963 piecesExpiration date March 2016 - June 2017
- STR10
3 lots432 piecesExpiration date Sept 2016 - Oct 2016
- PPH01
- Amount recalled
- 157,881 devices
Where it was sold
Why it was recalled
Stop using this product now
Ethicon Endo-Surgery initiated this voluntary global recall for specific production lots of PROXIMATE¿ PPH Hemorrhoidal Circular Stapler and Accessories 33mm (PPH01 and PPH03) and Transtar¿ Circular Stapler Procedure Set (STR10) due to difficulty firing the device which may result in incomplete firing stroke that may result in an incomplete staple formation.
Using this product could cause serious injury, illness or death — stop using it now.
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