Home / Recalls / Surgical Instrument Service And Savings, Inc. / Z-1625-2013

Z-1625-2013 Class II Terminated

Recalled by Surgical Instrument Service And Savings, Inc. — Redmond, OR

Recall Details

Product Type
Devices
Report Date
July 10, 2013
Initiation Date
May 3, 2013
Termination Date
July 11, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
13

Product Description

-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

Reason for Recall

The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.

Distribution Pattern

Nationwide Distribution.

Code Information

122300, 123263, 122490, 122753, 122406, 122675, 122309

Other recalls by Surgical Instrument Service And Savings, Inc.

  • Z-1630-2013 Class II — - Average Medium Blade 9mm x 25mm x 0.38mm Ref. 2296-3-111 Lot 122590, 122447 (May 3, 2013)
  • Z-1632-2013 Class II — Barron Radial Vacuum Trephine (1) Complete Trephine Set 9.0mm Dia. Ref. K20-2062 (May 3, 2013)
  • Z-1627-2013 Class II — -Scorpion Needle, For Use With Scorpion Suture Passer, (Blue). Ref. AR-13990N (May 3, 2013)
  • Z-1623-2013 Class II — -Instratek Carpal Tunnel Release Blades, (1) Triangle Blade, (1) Hook Blade. REF (May 3, 2013)
  • Z-1641-2013 Class II — - CLEAR-TRAC COMPLETE, Threaded Cannula with Obturator, (Grey) 7.0mm x 72mm Ref. (May 3, 2013)
  • Z-1640-2013 Class II — - ACCU-PASS Suture Shuttle, 70 Degree, Upbend, (Orange) Ref. 72200419 Lot 122504 (May 3, 2013)
  • Z-1643-2013 Class II — - ENDOPATH Resposable Bladeless Trocar, Non-Handled, w/Housing, 100mm, (Green) 1 (May 3, 2013)
  • Z-1629-2013 Class II — - Re-New II Endocut Scissor Tip, 16.51mm 5.0mm Ref. 3142 Lot 122295, 122308, 12 (May 3, 2013)
  • Z-1634-2013 Class II — Large Tear Cross Cut Rasp 14mm x 7mm Ref. 5100-37-114 Lot 122347 Manual s (May 3, 2013)
  • Z-1626-2013 Class II — GII QuickAnchor Plus, ETHIBOND Polyester Suture, 36", double-Armed w/CP 2 Needle (May 3, 2013)