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Recall Observatory FDA recall evidence

Device product

RUSCH Foley Urinary Catheter Insertion Tray with 10cc syringe, BZK Swabs, Sterile, Rx only, Teleflex Medical Product Code: 76730.

Z-2154-2014

July 10, 2014

Class III

Product summary

Firm
Teleflex Medical
Event
Event 68746
Status
Terminated
Classification
Class III
Quantity
720
Official record key
device-enforcement:Z-2154-2014

Official wording

Reason: Labeling error: The manufacturing date is the same as the expiration date. The manufacturing date is correct, however the expiration date incorrectly indicates that the product is expired.

Code information: Product Code: 76730, Lot number: 307505.

Distribution pattern: Nationwide distribution in CA, CT, FL, MA, MO, NJ, OH, OR and TX.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling error
  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    error: The manufacturing