Deltec Cozmo Insulin Pump, Model 1700, Smiths Medical International Ltd WD24 4LG UK, Smiths Medical MD, Inc., St Paul, M

FDA device recall Z-1622-2008 · posted 2008-08-15 · Terminated

Recall details

Recalling firm

Smiths Medical MD, Inc.

Reason for recall

Smith Medical discovered an issue with a motor component in specific serial numbers of the Deltec Cozmo Insulin Pump, Model Numbers 1700 and 1800. This issue affects how the motor operates and may cause an over-delivery of insulin which could result in injury to the user.

Action taken

Consignees were mailed an Urgent Medical Device Recall letter dated March 10, 2008. The Urgent letter addressed to "Distributors, Clinicans, Patients and Other Customers" contains Description of the Problem, Results of Investigation, and Advise on Action to be taken by the User. The patient users will be required to return a Recall Confrirmation Form. The USA distributors, USA prescribing physicians and the USA managed Care Accounts (Insurance Companies) will be mailed also a cover letter.

Root cause

Component change control

Status

Terminated

Product code

LZG

Quantity affected

436

Distribution

Class II Recall - Worldwide Distribution --- USA including states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME. RO, MN, MO, MS, ME, NC, ND, NE, NH, NJ, NM, NV, NY,

Date initiated

2008-03-10

Date posted

2008-08-15

Date terminated

2011-01-13

Location

Saint Paul, MN

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