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Recall Observatory FDA recall evidence

Device product

-Scorpion Needle, For Use With Scorpion Suture Passer, (Blue). Ref. AR-13990N Lot 123263 -SureFire Scorpion Needle (purple). Ref. AR-13991N Lot 123263 and 122279 -Suture Passing Wire. Ref. AR-1255-18 Lot 123190 Manual surgical instrument for general use.

Z-1627-2013

May 03, 2013

Class II

Product summary

Firm
Surgical Instrument Service And Savings, Inc.
Event
Event 65205
Status
Terminated
Classification
Class II
Quantity
6 units
Official record key
device-enforcement:Z-1627-2013

Official wording

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

Code information: 123263, 122279, 123190.

Distribution pattern: Nationwide Distribution.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    sterile barrier for reprocessed medical devices became compromised