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Recall Observatory FDA recall evidence

Device product

Gown Impervious , Code 900-3190, contains: GOWN IMPERVIOUS EXTRA LONG X-LARGE WITH TOWEL & WRAP Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

Z-2529-2014

May 20, 2014

Class I

Product summary

Firm
Customed, Inc
Event
Event 68536
Status
Terminated
Classification
Class I
Quantity
5 lots/312 units, multiple units per lot
Official record key
device-enforcement:Z-2529-2014

Official wording

Reason: Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Code information: 900-3190, 5 lots: 140111070 140211868 140312153 140412677 140513356

Distribution pattern: Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    packaging integrity may be compromised
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    loss of sterility