Reported Sep 17, 2014 · Terminated
PROXIMATE Skin Stapler. PROXIMATE RH Rotating-Head Skin Stapler (Model PRR35), PROXIMATE PX Fixed-Head Skin 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 Skin Stapler. PROXIMATE RH Rotating-Head Skin Stapler (Model PRR35), PROXIMATE PX Fixed-Head Skin Stapler (Model PXR35), Bulk/Non-Sterile PROXIMATE RH Rotating-Head Skin Stapler (Model CK 117), and Bulk/Non-Sterile PROXIMATE PX Fixed-Head Skin Stapler (Model CK 158). Skin stapler for use in a single patient, which is designed to apply rectangular stainless steel staples for routine wound closure.
- Lot codes and dates
- PROXIMATE RH Rotating-Head Skin Stapler (Model PRR35) Batch L4EG3F L4EK3Y L4EP22 L4ER1D L4ER9X L4EU87 PROXIMATE PX Fixed-Head Skin Stapler (Model PXR35) BatchBulk/Non-Sterile PROXIMATE RH Rotating-Head Skin Stapler (Model CK 117) Batch L91J4U L91K38 L91K6N L91M8N L91N22 L91W33 L91X5V Bulk/Non-Sterile PROXIMATE PX Fixed-Head Skin Stapler (Model CK 158) Batch
L4EG2TL4EH20L4EH85L4EK50L4EN58L4EN94L4EP2FL4EP6GL4ER1LL4EU0JL4EV07
L90W40L90X3CL90Y0UL90Y4VL90Z7CL9108ZL91151L91223L91970L91A7NL91C5CL91E2ZL91E6PL91G46L91J4LL91K3AL91M4UL91T81
- PROXIMATE RH Rotating-Head Skin Stapler (Model PRR35) Batch L4EG3F L4EK3Y L4EP22 L4ER1D L4ER9X L4EU87 PROXIMATE PX Fixed-Head Skin Stapler (Model PXR35) Batch
- Amount recalled
- 42,798
Where it was sold
Why it was recalled
The device may have a non-conforming component that may cause the device to fire an unformed staple.
This product could cause temporary or reversible health problems — stop using it.
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