One Touch Ping Glucose Management Systems Intended use: deliver insulin therapy

FDA device recall Z-2394-2010 · posted 2010-09-10 · Terminated

Recall details

Recalling firm

Animas Corporation

Reason for recall

sensor could be damaged

Action taken

An Email was sent by the firm, Animas, to US patients and health care providers where email addresses were on file. Animas sent two "URGENT: MEDICAL DEVICE CORRECTION " letters one dated March 18, 2010, to all US customers, HCPs and distributors of One Touch Ping Glucose Management System and the Animas 2020 Insulin Infusion Pump and the other letter to all US patients, HCPs and distributors of Animas 2020 Insulin Infusion Pump, Animas IR 1200 and Animas IR 1250 (1200 plus). Animas also notified all global distributors and affiliates and sent the letter to customers and health care professional in those regions. The letters describe the product, problem and action to be taken by the customers. The customers were instructed to follow their User Guide instructions; Pay attention to all pump warnings; NEVER rewind the pump motor, load the insulin cartridge, or prime their infusion set while connected, and fill out the enclosed reply card and send it back to Animas as soon as possible. Should you have any questions or concerns, please call the Animas Customer Support Department at 1-866-949-1525 or call toll free number on back of pump at 1-877-937-7867. If you are traveling outside of the U.S., please call 610-644-8990 and press option 1.

Root cause

Equipment maintenance

Status

Terminated

Product code

LZG

Distribution

Worldwide distribution: USA including states of CA,FL,LA, MA, MI, NY, OH, PA,TX, UT, VA and WA, and countries including Canada, United Kingdom, Finland, Germany, France, Hungary, Puerto Rico, Australi

Date initiated

2010-03-18

Date posted

2010-09-10

Date terminated

2010-10-27

Location

West Chester, PA

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