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Recall Observatory FDA recall evidence

Device product

Antibacterial Hydro Personal Catheter, Male 12 Fr, Product Code 63512, sold in boxes of 30 units

Z-0198-2016

October 02, 2015

Class III

Product summary

Firm
C.R. Bard, Inc.
Event
Event 72398
Status
Terminated
Classification
Class III
Quantity
4,170 each
Official record key
device-enforcement:Z-0198-2016

Official wording

Reason: Incorrect unit labeling. The case label and shelf box are correct, Product Code 63512 and Catheter Size 12 French. The unit label (catheter package) may state Product Code 63516 and Catheter Size 16 French.

Code information: Lot 53620131

Distribution pattern: Nationwide Distribution including CA, FL, IL, MO, NJ, OR, PA, TX & WA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Incorrect unit labeling. The case label and shelf box are correct, Product Code 63512 and Catheter Size 12 French. The unit label (catheter package) may state Product Code 63516 and Catheter Size 16 French.