Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1381-2021Class II

VGlove NITRILE *** Protect Your Life 100 Patient examination gloves

Hubo International Inc / initiated 2020-10-23 / Open, Classified / root cause: labeling and UDI

HUBO INTERNATIONAL INC began a recall of VGlove NITRILE *** Protect Your Life 100 Patient examination gloves on . FDA classified it as Class II and gives the reason as "Package labeled as nitrile gloves, contains latex gloves". As of , the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-1381-2021
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Hubo International Inc
Product
VGlove NITRILE *** Protect Your Life 100 Patient examination gloves
Product code
LZA Polymer Patient Examination Glove
Reason for recall
Package labeled as nitrile gloves, contains latex gloves.
Root cause tag
labeling and UDI
FDA root cause
Unknown/Undetermined by firm
Action
On or about 10/23/2020, the firm contacted its customer via telephone call or email that boxes of gloves labeled as nitrile contained latex gloves. Customers were advised to hold product. All product were to be returned to the Broker. Any questions regarding this recall action - contact Sales Director at 626-586-3290 or at email [email protected]
Quantity in commerce
28,450 boxes (100 gloves per box)
Distribution
U.S.: CA O.U.S.: None
Product codes and lots
Lot Number: 0 320 302

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1381-2021
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1381-2021Class IIOngoingVoluntary: Firm initiated