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Recall Observatory FDA recall evidence

Device product

O.R. TOWELS- CUSTOMED- (6) TOWELS CLOTH HUCK BLUE ( I) WRAPPER 20" X 20 EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

Z-2339-2014

May 20, 2014

Class I

Product summary

Firm
Customed, Inc
Event
Event 68536
Status
Terminated
Classification
Class I
Quantity
26 lots; 3875 units (multiple units per lots)
Official record key
device-enforcement:Z-2339-2014

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: Product code 900-629, 26 lots: 109061450 109102339 110030682 110041125 110071851 110123058 111020294 111020444 111040911 111051251 111092555 111113133 112010193 112030734 112072918 112124704 113036701 113046967 113047229 113057748 113088880 131110309 131110345 140312179 140513154 140613796

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