| | Class 2 Recall
Roche ACCU-CHEK Spirit Plus insulin pump |  |
| Date Posted |
May 26, 2009 |
| Recall Number |
Z-1646-2009 |
| Product |
Roche ACCU-CHEK Spirit insulin pump. Part numbers 4540492001, 4759702001 and 4759729001. |
| Code Information |
All units with serial numbers SN02119552 thru SN10006093.
|
Recalling Firm/
Manufacturer |
Disetronic Medical Systems, Inc.
11800 Exit 5 Pkwy Ste 120
Fishers, Indiana 46037-7989 |
| Consumer Instructions |
Contact the recalling firm for information |
Reason for
Recall |
The "up" and "down" buttons, which are used for changing the program in the menu or to administer additional insulin through a bolus delivery, may experience intermittent failure or completely cease to operate.
|
| Action |
The firm issued a press release on 4/30/09 and sent letters with attached Urgent Medical Device Recall (Field Corrective Action) notification dated 5/4/09 to distributors, health care providers and users. Disetronic will replace pumps within the affected serial numbers (SN02119552 to SN10006093) that have intermittent or complete loss of function of the up and/or down button promptly upon contact from the customer with a new pump that is not affected by the potential button failure. For pumps within the affected serial numbers (SN02119552 to SN10006093) which are functioning properly, no replacement is available/possible at this time. Disetronic will gradually phase in replacement pumps for the remaining pumps within the affected range, as they become available. Customers are to complete the enclosed Customer Reply Card to acknowledge receipt of the notification.
On 5/17/11, after being notified of the recall's ineffectiveness (in that only 40% of the pumps had been replaced), the firm re-issued recall notification letters including the aforementioned information to their consignees. |
| Quantity in Commerce |
14,929 |
| Distribution |
Worldwide Distribution -- USA and Canada. |
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