Recall Z-0928-2012 ยท EOB Nasopharyngoscope (Flexible Or Rigid)
Vision-Sciences, Inc.
Product is a lithium ion battery charger sold as both a stand-alone accessory, and as part of endoscopy system sets. --- Stand alone labeling: Vision Sciences Battery Charger, Lithium Ion [REF] 07-3051; [MFG Symbol] Vision-Sciences, Inc., 40 Ramland Road South, Orangeburg, NY 10962 USA. Accessory to endoscopy kits used to charge/recharge lithium ion batteries.
| Date | Jan 29, 2012 (initiated Dec 27, 2011) |
| Status | Terminated |
| Reason | Vision-Sciences is recalling the Vision-Sciences Battery Charger due to reports relating to the potential for over-heating and possible burning of the lithium-ion batteries being charged. |
| Root cause | Nonconforming Material/Component |
| Action | Vision Sciences sent an "URGENT: PRODUCT RECALL NOTIFICATION" letter dated December 27, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to remove the affected product from inventory. A Tracking/Verification Form was provided for customers to complete and return to the firm. Contact the firm at 800-874-9975 for questions regarding this recall. |
| Quantity | 1618 units |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |