Date Initiated by Firm |
October 09, 2008 |
Date Posted |
November 05, 2008 |
Recall Status1 |
Terminated 3 on July 06, 2010 |
Recall Number |
Z-0284-2009 |
Recall Event ID |
49606 |
510(K)Number |
K033373
|
Product Classification |
Insulin Syringe - Product Code FMI
|
Product |
ReliOn Insulin syringes - 1cc, 31 G Distributed by: Can-Am Care, Corp., Alpharetta, GA |
Code Information |
Lot Number 813900 (Lot number is located on packaging for individual syringes) |
Recalling Firm/ Manufacturer |
Covidien LP 15 Hampshire St Mansfield MA 02048-1113
|
For Additional Information Contact |
SAME 508-261-8000
|
Manufacturer Reason for Recall |
Mislabeled: Package labeled as an insulin syringe for use with U-100 insulin contains an insulin syringe for use with U-40 insulin. Risk of overdose of insulin.
|
FDA Determined Cause 2 |
Process design |
Action |
Tyco Healthcare Group LP (Covidien) notified Can-Am Care, Corp. by letter sent by e-mail and by Federal Express on 10/9/08. The letter requests that they immediately inventory, quarantine any remaining stock they may have of the product, return, and notify their customers. Wal-Mart conducted a consumer mailing on October 14, 2008, and is posting placards in their stores. Can-Am Care, whose name appears on the label of the product has concurrently posted a recall notice on their website. |
Quantity in Commerce |
471,000 (4710 boxes of 100) |
Distribution |
Nationwide |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = FMI and Original Applicant = TYCO HEALTHCARE
|