Reported Jul 10, 2013 · Terminated
-ENDOPATH ETS-Flex Articulating Endoscopic Linear Cutter, (Blue) w/o Staples 35mm. REF ATB35 Lot 122300. -Ligaclip MCA…
Surgical Instrument Service And Savings, 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: Surgical Instrument Service And Savings, Inc. · 2747 Sw 6th St · Redmond, OR · 97756-7109
Is this the product you have?
17 of 17 products
| Model / number | Product as published |
|---|---|
ATB35 | — |
| — | Lot 122300. -Ligaclip MCA Multiple Clip Applier, 20 Small Clips Small. |
MCS20 | — |
| — | Lot 122300. - Ethicon Pistol Grip, Fixed Head Skin Stapler, Multi-Directional Release, (Grey) 35W. |
PXW35 | — |
| — | Lot 122309 and |
| — | Lot 123263. -Proximate Linear Cutter, w/o Staples 75mm. |
TLC75 | — |
| — | Lot 122490 -Ethicon Proximate Plus MD, Skin Stapler Regular. |
PMR35 | — |
| — | Lot 122753. -Proximate Plus, Rotating Head, Skin Stapler (White) Wide. |
PRW35 | — |
| — | Lot 122406. - Ethicon PROXIMATE PLUS, Skin Stapler, Pistol Grip, Fixed Head, Multi-Directional Release, (Grey) Regular. |
PXR35 | — |
| — | Lot 122675 and |
TX60B | Lot 123263. -TX Reloadable Linear Stapler 3.5mm Leg, w/o Staples 60mm. |
| — | Lot 122490 Manual surgical instrument for general use |
- Lot codes and dates
122300123263122490122753122406122675122309
- Amount recalled
- 13
This recall covers 22 products
The agency filed one notice per product. You are reading one of them; the other 21 are below.
9 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
This product could cause temporary or reversible health problems — stop using it.
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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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