—#140214

Product

Ambitex NMD400 Nitrile Exam Gloves size medium. General Hospital and Personal use. Intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.

FDA product code: LZA — Polymer Patient Examination Glove
Device class: Class 1
Medical specialty: General Hospital
510(k) numbers: K110979
Affected lot / code info: Ambitex NMD400 Nitrile Exam Glove LOT NUMBER: 25314

Why it was recalled

Ambitex Nitrile NMD400 Exam Gloves size medium on exam hold were inadvertently placed into commerce. The product was under Exam Hold because samples pulled from a shipment manufactured by the firm failed the water leak test performed by FDA as described at 21 CFR 800.20.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

The firm sent an Urgent: Product Recall letter dated 8/25/2015. The firm is requesting the user discontinue using and return any remaining stock of the AMBITEX Nitrile Exam Gloves because the gloves were inadvertently shipped prior to U.S. FDA releasing them for sale. Additionally, the firm requests that the customer quarantine the affected examination gloves; and return a copy of the enclosed Acknowledgment Form confirming their receipt of the Urgent recall via fax to 216-651-9760. Customer Service should be contacted at 800-GLOVES-0 to arrange for the return and credit of any on hand product that customer may have. If the customer has further distributed the affected gloves they are advised to notify their customers of the recall.

Recalling firm

Firm: Cardinal Health
Address: 1300 Waukegan Rd, Waukegan, Illinois 60085-6724

Distribution

Distribution pattern: Nationwide Distribution.

Timeline

Recall initiated: 2015-08-25
Terminated: 2016-08-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #140214. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.