Recall Z-0929-2012

Vision-Sciences, Inc. · initiated December 27, 2011

Terminated

Product

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.

Codes / lots: All units are affected. Products which include this item are VISION SCIENCES CAT. No. ITEM Description; 07-3051 Battery Charger, Lithium-Ion; 07-3051X Battery Charger, Lithium-Ion*; 07-3053 BLS Kit; 07-3053X BLS Kit*; 07-3052 Rechargeable Batteries, Lithium-Ion; 07-3052X Rechargeable Batteries, Lithium-Ion*; 02-2602 ENT-3000 Scope (Standard Set); 02-2602-IN ENT-3000 Scope (Standard Set)*; 02-2602X ENT-3000 Scope (Standard Set)*; 02-4201 ENT-4000 Portable Set; 02-4201X ENT-4000 Portable Set*; * These products were distributed by Medtronic Xomed/ENT.

Reason for recall

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.

FDA-determined cause: Nonconforming Material/Component

Action taken

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.

Details

Recall number
Z-0929-2012
Initiated
December 27, 2011
Posted by FDA
January 29, 2012
Terminated
July 6, 2018
Product code
EOB – Nasopharyngoscope (Flexible Or Rigid)
Quantity
3628 batteries
Distribution
Worldwide Distribution
Recalling firm
Vision-Sciences, Inc., Orangeburg, NY

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-0928-2012 Product is a lithium ion battery charger sold as both a stand-alone accessory, and as…Vision-Sciences is recalling the Vision-Sciences Battery Charger due to reports relating to the potential… 12/27/2011Terminated