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Z-0291-2009

Battery Caps used with OneTouch Ping Glucose Monitoring System. The pump is used to help maintain blood...

Animas Corp. / initiated 2008-08-04 / Terminated / root cause: manufacturing process
FDA source (opens on fda.gov)

Animas Corporation began a recall of Battery Caps used with OneTouch Ping Glucose Monitoring System. The pump is used to help maintain blood glucose targets on . The reason FDA records is "Unintentional rebooting: Pump products exhibit an intermittent loss of power due intermittent loss of contact between battery cap and battery canister resulting in the device resetting. The failure of the battery cap...". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-0291-2009
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Animas Corp.
Product
Battery Caps used with OneTouch Ping Glucose Monitoring System. The pump is used to help maintain blood glucose targets.
Product code
LZG Pump, Infusion, Insulin
Reason for recall
Unintentional rebooting: Pump products exhibit an intermittent loss of power due intermittent loss of contact between battery cap and battery canister resulting in the device resetting. The failure of the battery cap may result in failure of the device to administer insulin therapy which may result in hyperglycemia.
Root cause tag
manufacturing process
FDA root cause
Nonconforming Material/Component
Action
The recalling firm issued a notification letter to the patients with insulin pumps on 8/5/08 to inform them of the problem and that they needed to replace the battery. The recalling firm contacted OneTouch Ping users by telephone on 8/5/08 for this issue and another issue. The recalling firm issued letters to distributors informing them of the problem and notified customers to replace the batteries. In addition, a letter was issued to physicians to alert them of the situation with regard to current patients. Consumers can contact 1-800-423-4087 for additional information or questions.
Quantity in commerce
251 units
Distribution
Worldwide Distribution including USA (AR, CA, FL, KY, LA, MA, NE, OH, PA, SC, SD, TN, and UT) and countries of Australia, Austria, Canada, Czech Republic, Finland, France, Israel, Italy, New Zealand, Spain, Switzerland, and Sweden.
Product codes and lots
Part Numbers: 100-430-00, 100-431-00, 100-432-00, 100-434-00, and 100-435-00. Serial Numbers: 01-02000-1, 02-02001-15, 03-2002-15, 03-02003-15, 04-0201 0-15, 05-02004-15, 05-02011-15, 06-02012-15, 06-02100-15, 07-02013-15, 07-02101-15, 08-02007-15, 08-02102-15, 09-02008-15, 09-02110-15, 10-02009-15, 10-02104-15, 10-02111-15, 11-02112-15, 12-02032-15, 12-02106-15, 12-02113-15, 12-02120-15, 13-02033-15, 13-02040-15, 13-02107-15, 13-02121-15, 13-02202-15, 14-02027-15, 14-02034-15, 14-02108-15, 14-02203-15, 14-02210-15, 15-02028-15, 15-02035-15, 15-02042-15, 15-02123-15, 15-02204-15, 16-02029-15, 16-02036-15, 16-02050-15, 16-02117-15, 16-02124-15, 16-02131-15, 16-02205-15, 16-02300-15, 17-02037-15, 17-02051-15, 17-02118-15, 17-02132-15, 17-02213-15, 17-02220-15, 18-02038-15, 18-02126-15, 18-02140-15, 18-02221-15, 19-02039-15, 19-02053-15, 19-02060-15, 19-02127-15, 19-02208-15, 19-02222-15, 20-02047-15, 20-02054-15, 20-02142-15, 20-02209-15, 20-02216-15, 20-02223-15, 20-02304-15, 21-02048-15, 21-02129-15, 21-02136-15, 21-02143-15, 21-02150-15, 21-02217-15, 21-02224-15, 21-02231-15, 22-02049-15, 22-02056-15, 22-02063-15, 22-02144-15, 22-02151-15, 22-02225-15, 22-02232-15, 23-02057-15, 23-02071-15, 23-02152-15, 23-02219-15, 23-02233-15, 23-02240-15, 24-02058-15, 24-02065-15, 24-02072-15, 24-02139-15, 24-02160-15, 24-02241-15, 25-02059-15, 25-02066-15, 25-02080-15, 25-02147-15, 25-02228-15, 25-02235-15, 26-02148-15, 26-02155-15, 26-02162-15, 26-02236-15, 26-02243-15, 26-02250-15, 26-02331-15, 27-02149-15, 27-02156-15, 27-02163-15, 27-02237-15, 27-02244-15, 28-02076-15, 28-02090-15, 28-02157-15, 28-02164-15, 28-02171-15, 28-02245-15, 28-02319-15, 28-02333-15, 29-02091-15, 29-02158-15, 29-02172-15, 29-02246-15, 29-02253-15, 29-02260-15, 30-02092-15, 30-02166-15, 30-02173-15, 30-02180-15, 30-02247-15, 30-02254-15, 30-02261-15, 30-02342-15, 31-02093-15, 31-02167-15, 31-02248-15, 31-02255-15, 31-02262-15, 31-02336-15, 32-02094-15, 32-02168-15, 32-02175-15, 32-02256-15, 32-02263-15, 32-02351-15, 33-02088-15, 33-02169-15, 33-02176-15, 33-02190-15, 33-02345-15, 34-02096-15, 34-02177-15, 34-02184-15, 34-02191-15, 34-02258-15, 35-02178-15, 35-02185-15, 35-02192-15, 35-02259-15, 36-02098-15, 36-02186-15, 36-02193-15, 36-02348-15, 37-02099-15, 37-02195-15, 39-02189-15, 39-02196-15, 40-01901-15, 40-02197-15, 41-02198-15, 42-01910-15, 42-02199-15, 43-01911-15, 44-01912-15, 45-01906-15, 45-01913-15, 45-01920-15, 48-01909-15, 48-01930-15, 49-01924-15, 49-01931-15, 50-01918-15, 50-01925-15, 51-01926-15, 51-01940-15, 52-01927-15, 52-01934-15, 52-01941-15, 53-01928-15, 53-01942-15, 54-01936-15, 54-01943-15, 54-01950-15, 55-01951-15, 56-01864-15, 56-01938-15, 56-01952-15, 57-01939-15, 57-01946-15, 57-01953-15, 57-01960-15, 58-01866-15, 58-01873-15, 58-01947-15, 58-01961-15, 59-01874-15, 59-01948-15, 59-01948-15, 60-01868-15, 60-01882-15, 60-01949-15, 60-01963-15, 60-01970-15, 61-01869-15, 61-01876-15, 61-01883-15, 61-01890-15, 61-01957-15, 62-01877-15, 62-01884-15, 62-01891-15, 62-01958-15, 63-01885-15, 63-01892-15, 63-01959-15, 63-01973-15, 64-01886-15, 64-01893-15, 64-01974-15, 64-01981-15, 65-01887-15, 67-01889-15, 67-01896-15, 67-01991-15, 68-01897-15, 68-01985-15, 68-01992-15, 69-01898-15, 69-01979-15, 69-01993-15, 70-01899-15, 70-01987-15, 70-01994-15, 71-01995-15, 72-01996-15, 73-01997-15, 74-01998-15, and 75-01999-15.