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U.S. Department of Health and Human Services

Class 2 Device Recall Vision Sciences Battery

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  Class 2 Device Recall Vision Sciences Battery see related information
Date Initiated by Firm December 27, 2011
Date Posted January 29, 2012
Recall Status1 Terminated 3 on July 06, 2018
Recall Number Z-0929-2012
Recall Event ID 60806
510(K)Number K050972  K100125  
Product Classification Nasopharyngoscope (flexible or rigid) - Product Code EOB
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.
Code Information 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.
Recalling Firm/
Manufacturer		 Vision-Sciences, Inc.
40 Ramland Rd S
Orangeburg NY 10962-2623
For Additional Information Contact Lillian Quintero
845-848-1063
Manufacturer 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 2		 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 in Commerce 3628 batteries
Distribution Worldwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = EOB and Original Applicant = VISION-SCIENCES, INC.
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