FDA Recall Terminated

Product is a lithium ion battery sold as both a stand-alone accessory, and as part of endoscopy system sets. Stand alone labeling: Vision Sciences Rechargeable Lithium Ion Batteries, Replacement (2) [REF] 07-3052; [MFG Symbol] Vision-Sciences, Inc., 40 Ramland Road South, Orangeburg, NY 10962 USA. Accessory to endoscopy kits used to charge/recharge lithium ion batteries.

Recall: Z-0929-2012 · Initiated December 27, 2011

Recall

Recall Number
Z-0929-2012
Event Number
60806
Firm
Vision-Sciences, Inc.
FEI Number
2242464
Product Code
EOB
Status
Terminated
Root Cause
Nonconforming Material/Component
Initiated
December 27, 2011
Posted
January 29, 2012
Terminated
July 6, 2018
Address
40 Ramland Rd S, Orangeburg, NY, 10962-2623

Description

Product is a lithium ion battery sold as both a stand-alone accessory, and as part of endoscopy system sets. Stand alone labeling: Vision Sciences Rechargeable Lithium Ion Batteries, Replacement (2) [REF] 07-3052; [MFG Symbol] Vision-Sciences, Inc., 40 Ramland Road South, Orangeburg, NY 10962 USA. Accessory to endoscopy kits used to charge/recharge lithium ion batteries.

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.

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.

Distribution

Worldwide Distribution

Quantity

3628 batteries