Z-0712-2012

Phantom-brand Black Latex Powder Free Examination Gloves, 100 gloves by weight, size small and Medium...

Name: Z-0712-2012 Phantom-brand Black Latex Powder Free Examination Gloves, 100 gloves by weight, size small and Medium...
Creator: Adenna Inc
Published: 2011-12-22
License: https://open.fda.gov/license/

Adenna Inc / initiated 2011-12-22 / Terminated

FDA source

Adenna Inc began a recall of Phantom-brand Black Latex Powder Free Examination Gloves, 100 gloves by weight, size small and Medium, Product Code PHM912, Lot No. 002-E1LF302-1, Manufacture... on 2011-12-22. The reason FDA records is "The recall was initiated because Adenna Inc. distributed latex gloves that have been FDA refused". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0712-2012
Status: Terminated
Initiated: 2011-12-22
Posted: 2012-01-11
Terminated: 2012-05-29
Recalling firm: Adenna Inc
Product: Phantom-brand Black Latex Powder Free Examination Gloves, 100 gloves by weight, size small and Medium, Product Code PHM912, Lot No. 002-E1LF302-1, Manufacture date JUL 2011, Size Small Product Code PHM915, Lot No. 002-E1LF305-1, Manufacture date JUL 2011, Size Medium Examination Disposable Gloves
Product code: LYY Latex Patient Examination Glove
Reason for recall: The recall was initiated because Adenna Inc. distributed latex gloves that have been FDA refused.
FDA root cause: Release of Material/Component prior to receiving test results
Action: Adenna Inc. sent a recall letter dated December 22, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to examine their inventory and quarantine the products that are subject to the recall. Customers were instructed to notify their customers if they have further distributed the products. Customers were instructed to cease using the recalled products, and Adenna will replace the products. Customers were instructed to complete and return the enclosed response form as soon as possible. Customers with any questions can contact their account manager at (888) 3ADENNA (1-888-323-3662) for futher assistance.
Quantity in commerce: 427 cartons
Distribution: Nationwide Distribution including the states of: FL, CA, NY, NV, NC, MD, TX, OR, AZ, OH, MN, and IL.
Product codes and lots: Lot No. 002-E1LF302-1 and Lot No. 002-E1LF305-1

Product code LYY

K100694Class IColored Powder Free and Polymer Coated Examination Glove (Blue, Black and Pink) with a Protein Claim of Less ThanTekmedic (M) Sdn Bhd / cleared 2010-06-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)