Deltec Cozmo 3 mL Insulin Cartridge 의 리콜

Recall

30401

Class 2

Z-0566-05

2004-10-15

2005-02-26

Terminated

United States

2006-06-25

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35809

Smiths medical md, inc. (smmd) has received several complaints relating to two lots of cozmo cartridges describing leakage of insulin into the cartridge chamber. firm expanded recall 03/17/05 to include one more lot, based on in-house testing and review of customer complaints.

Consignees were mailed Customer Recall Notification Letter on 10/15/04. Customers are to inspect their inventory for the affected lot numbers and contact Smiths Medical Customer Services Department and return any unused Insulin Cartridges to Smiths Medical, who will replace the returned Insulin Cartridges. EXPANDED RECALL Customers were notified with an Urgent: Product Safety & Recall Notification beginning 03/17/05 with similar instructions as in the previous Notification. Customers are to inspect their inventory for the affected lot number, contact Smiths Medical Diabetes System Customer Service Department to make arrangements to have the unused Insulin Cartridges from the affected lot number returned to Smiths Medical, who will provide replacement cartridges.