Deltec Cozmo 3 ml Insulin Cartridge with 0.7mm(22G) x 12.5mm (1/2 in.) needle and cap. Reorder No. 21-1750-24. Immediate

FDA device recall Z-0566-05 · posted 2005-02-26 · Terminated

Recall details

Recalling firm

Smiths Medical MD, Inc.

Reason for recall

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.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

LZG

Quantity affected

2886 boxes (25 cartridges per box); EXPANDED RECALL additional 1440 boxes

Distribution

nationwide. Product only distributed within the US.

Date initiated

2004-10-15

Date posted

2005-02-26

Date terminated

2006-06-25

Location

Saint Paul, MN

Related 510(k) clearances