Home / Recalls / Surgical Instrument Service And Savings, Inc. / Z-1643-2013

Z-1643-2013 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
259

Product Description

- ENDOPATH Resposable Bladeless Trocar, Non-Handled, w/Housing, 100mm, (Green) 10/11mm Ref. 511NA Lot 123215, 122647 - ENDOPATH Resposable Bladeless Trocar, Non-Handled, w/Housing, 100mm, (Orange) 5.0mm Ref. 35LNA Lot 123215, 122647 - ENDOPATH Resposable Trocar w/Dilating Tip Obturator & Housing, 100mm, (Orange) 5mm Ref. 35LDA Lot 122647 - ENDOPATH Resposable Trocar, Dilating Tip w/Housing, 100mm, (Purple) 10/12mm Ref. 512DA Lot 123215 - ENDOPATH Sleeve Housing (Orange) 5mm Ref. 355HR Lot 123215, 122647 Endoscope and accessories - ENDOPATH Trocar, Disposable Sleeve Housing, (Green) 10/11mm Ref. 511HR Lot 122647 - ENDOPATH Blunt Tip Obturator & Housing, w/Olive Plug, 100mm, (Purple) 10/12mm Ref. 512BA Lot 122647 - ENDOPATH Resposable Trocar w/ Dilating Tip Obturator & Housing, 100mm, (Green) 10/11mm Ref. 511DA Lot 122454, 122647 - ENDOPATH, Bladeless Trocar with Stability Sleeve, Non-handled 10/12mm Ref. 512NT Lot 123254 - ENDOPATH Xcel Bladeless Trocar, Handled, w/Stability Sleeve, (Teal) 11mm x 100mm Ref. 811LTH Lot 122300 - ENDOPATH Xcel Bladeless Trocar, w/Stability Sleeve 12mm x 150mm Ref. B12XT Lot 122300 - ENDOPATH Xcel Bladeless Trocar, w/Stability Sleeve 5.0mm x 150mm Ref. B5XT Lot 122429 - ENDOPATH Xcel Bladeless Trocar, w/Stability Sleeve, (Teal) 11mm x 100mm Ref. B11LT Lot 122454, 123254, 122429 - ENDOPATH Xcel Bladeless Trocar, w/Stability Sleeve, 100mm Length 5.0mm Ref. B5LT Lot 122347, 122454, 122592, 122490, 123254, 122429, 122300 - ENDOPATH Xcel Bladeless Trocar, w/Stability Sleeve, 75mm Length, (Teal) 5.0mm Ref. B5ST Lot 123254 - ENDOPATH Xcel Blunt Tip Trocar, w/Smooth Sleeve & Adjustable Plug, (Purple) 12mm x 100mm Ref. H12LP Lot 122338, 122372, 123254, 123215 - ENDOPATH Xcel Dilating Tip Trocar, w/Stability Sleeve, (Gold) 11mm x 100mm Ref. D11LT Lot 122454 - ENDOPATH Xcel Dilating Tip Trocar, w/Stability Sleeve, (Gold) 12mm x 100mm Ref. D12LT Lot 122454 - ENDOPATH Xcel Dilating Tip Trocar, w/Stability Sleeve, (Gold) 5.0mm x 100mm Ref. D5LT Lot 122338, 122454, 122490, 122429 - ENDOPATH Xcel Integrated Stability Trocar Sleeve 11mm x 100mm Ref. CB11LT Lot 122429 - ENDOPATH Xcel Integrated Stability Trocar Sleeve 12mm x 100mm Ref. CB12LT Lot 122490 - ENDOPATH Xcel Integrated Stability Trocar Sleeve 5.0mm x 100mm Ref. CB5LT Lot 122490, 122429, 122300 - Kii Optical Access System Threaded (Blue) 5mm x 100mm Ref. C0Q04 Lot 122609

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

122338, 122347, 122454, 122592, 123372, 122490, 122490, 123254, 122609, 122429, 123215, 122647, 122300.

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-1629-2013 Class II — - Re-New II Endocut Scissor Tip, 16.51mm 5.0mm Ref. 3142 Lot 122295, 122308, 12 (May 3, 2013)
  • Z-1625-2013 Class II — -ENDOPATH ETS-Flex Articulating Endoscopic Linear Cutter, (Blue) w/o Staples 35m (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)