Recall Z-0133-2016 ยท LZA Polymer Patient Examination Glove
Cardinal Health
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.
| Date | Aug 25, 2015 |
| Status | Terminated |
| Reason | 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 | Nonconforming Material/Component |
| Action | 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 produ |
| Quantity | 34 cases. |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110979 | DERMAGRIP ULTRA POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES NON-STERILE,TESTED FOR USE W/ CHEMOTHERAPY DRUGS Advanced Medical Products Sdn Bhd, Oct 20, 2011 |