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Recall Observatory FDA recall evidence

Device product

- IDEAL 30 Suture Grasper (Green) 30 Degree Ref. 251721 Lot 122511 - IDEAL 60 Suture Grasper (Pink) 60 Degree Ref. 251723 Lot 122631 Passer

Z-1636-2013

May 03, 2013

Class II

Product summary

Firm
Surgical Instrument Service And Savings, Inc.
Event
Event 65205
Status
Terminated
Classification
Class II
Quantity
2
Official record key
device-enforcement:Z-1636-2013

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: 122511, 122631.

Distribution pattern: Nationwide Distribution.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    sterile barrier for reprocessed medical devices became compromised