Integra LED Battery Charger, Single Bay. Product Number: 90523 The LED Headlight System Battery Charger (90523) is an ac

FDA device recall Z-1976-2014 · posted 2014-07-02 · Terminated

Recall details

Recalling firm

Integra LifeSciences Corp.

Reason for recall

LED battery chargers may prematurely fail and will not charge the LED battery as intended

Action taken

Integra initiated a voluntary recall on June 11, 2014 to consignees that have been shipped affected product lots of Integra LED Battery Chargers, Catalogue No. 90523. The written notifications were delivered to US consignees by traceable courier service and non-US consignees by traceable email or facsimile. The consignee notification: Advises them of the nature of the issue and the potential for an adverse patient consequence. Advises them to review their inventory and how to determine if they have affected battery chargers. Advises them to immediately stop the use or distribution of any affected product lot numbers they may have. Requests they identify and report to Integra if they do or do not have any unexpired affected product lots. Advises them replacements battery chargers will be shipped for any affected products they affirm are in their possession and how to return their affected product. Questions regarding these instructions, please contact Integra Customer Service at 1-800-431-1123 or your Integra sales

Root cause

Manufacturing material removal

Status

Terminated

Product code

HPP

Quantity affected

1250 battery chargers

Distribution

Worldwide Distribution - US Nationwide and the countries of Canada, Australia, Arab Emirates, Denmark, Germany, Great Britain, India, Ireland, Israel, Japan, Kuwait, Lebanon, Malta., Netherlands, Pana

Date initiated

2014-06-11

Date posted

2014-07-02

Date terminated

2014-12-19

Location

Plainsboro, NJ