Reported Jan 16, 2019 · Terminated
PROXIMATE¿ PPH Hemorrhoidal Circular Stapler Product Code:PPH03 PPH03: The PROXIMATE¿ PPH Hemorrhoidal Circular Stapler…
Ethicon Endo-Surgery Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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 · Blue Ash, OH · 45242-2803
Is this the product you have?
- PROXIMATE¿ PPH Hemorrhoidal
- Circular Stapler Product CodePPH03
- PPH03The PROXIMATE¿ PPH Hemorrhoidal Circular Stapler and Accessories have application throughout the anal canal to perform surgical treatment of hemorrhoidal disease
- Lot codes and dates
- Lot Codes
P93K95P9420YP94A4TP93L1MP9420ZP94D3NP93M3GP9441HP94F3ZP93T35P9450LP94G04P93T7FP9463JP94H5FP93W3MP94765P94J4WP93W3NP9487ZP94J80P93Y58P94901P94K2AP94117P94A20R9200Z
- Lot Codes
- Amount recalled
- 15,264 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Hemorrhoidal Circular Stapler may have been assembled without a washer, this may potentially cause bleeding or soft tissue injury during use as the device may not fully cut when fired
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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