| Date Initiated by Firm | October 23, 2020 |
|---|
| Create Date | April 09, 2021 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1381-2021 |
|---|
| Recall Event ID |
87447 |
| 510(K)Number | K151208 |
|---|
| Product Classification |
Polymer patient examination glove - Product Code LZA
|
| Product | VGlove NITRILE *** Protect Your Life 100 Patient examination gloves |
|---|
| Code Information |
Lot Number: 0 320 302 |
| FEI Number |
3016755429
|
Recalling Firm/
Manufacturer |
HUBO INTERNATIONAL INC
9528 Rush St Ste E
South El Monte CA 91733-1551
|
| For Additional Information Contact | James Chung
626-586-3290 |
|---|
Manufacturer Reason
for Recall | Package labeled as nitrile gloves, contains latex gloves. |
|---|
FDA Determined
Cause 2 | 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 James@hubo-sports.com |
|---|
| Quantity in Commerce | 28,450 boxes (100 gloves per box) |
|---|
| Distribution | U.S.: CA
O.U.S.: None |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
| 510(K) Database | 510(K)s with Product Code = LZA
|
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