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Surgical Instrument Service And Savings, Inc. recalls -ENDOPATH ETS-Flex Articulating Endoscopic Linear Cutter, (Blue) w/o Staples 35mm. REF ATB35 Lot 122300. -Ligaclip MC
Recalled July 10, 2013 · FDA recall Z-1625-2013 · Surgical Instrument Service And Savings
Hazard
The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch. · FDA Class II
Units
13
Sold at
Nationwide Distribution.
Description
The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
Product
-ENDOPATH ETS-Flex Articulating Endoscopic Linear Cutter, (Blue) w/o Staples 35mm. REF ATB35 Lot 122300. -Ligaclip MCA Multiple Clip Applier, 20 Small Clips Small. REF MCS20 Lot 122300. - Ethicon Pistol Grip, Fixed Head Skin Stapler, Multi-Directional Release, (Grey) 35W. REF PXW35 Lot 122309 and Lot 123263. -Proximate Linear Cutter, w/o Staples 75mm. REF TLC75 Lot 122490 -Ethicon Proximate Plus MD, Skin Stapler Regular. REF PMR35 Lot 122753. -Proximate Plus, Rotating Head, Skin Stapler (White) Wide. REF PRW35 Lot 122406. - Ethicon PROXIMATE PLUS, Skin Stapler, Pistol Grip, Fixed Head, Multi-Directional Release, (Grey) Regular. REF PXR35 Lot 122675 and Lot 123263. -TX Reloadable Linear Stapler 3.5mm Leg, w/o Staples 60mm. Ref. TX60B Lot 122490 Manual surgical instrument for general use
Manufacturer(s)
Surgical Instrument Service And Savings, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →