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U.S. Department of Health and Human Services

Class 2 Device Recall Live Better U100 Insulin Syringe

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 Class 2 Device Recall Live Better U100 Insulin Syringesee related information
Date Initiated by FirmFebruary 05, 2010
Date PostedMarch 31, 2010
Recall Status1 Terminated 3 on May 07, 2011
Recall NumberZ-1217-2010
Recall Event ID 54655
510(K)NumberK062702 
Product Classification syringe, piston - Product Code FMF
ProductLive Better 1cc, 31 gauge x 5/16 inch U-100 Insulin Syringe short needle. 100 syringes, Manufactured by UltiCare. Used to draw a quantity of pharmaceutical from its container and allow administration of the pharmaceutical directly to the patient. As an alternative use the product will allow administration of the pharmaceutical to the patient via an intravenous port, heparin lock or saline lock.
Code Information Lot 171124
Recalling Firm/
Manufacturer		 Ulti Med, Inc.
287 6th St E Ste 20
Saint Paul MN 55101-1655
For Additional Information ContactHolly Hartshorn
651-291-7909
Manufacturer Reason
for Recall		UltiMed, Inc. is recalling one lot of 1cc, 31 gauge x 5/16 inch U-100 Insulin Syringe Live Better because it is mislabeled and actually contains 1/2 cc, 30 gauge x 1/2 inch U-100 insulin Syringe.
FDA Determined
Cause 2		Employee error
ActionAn " IMPORTANT - DEVICE PRODUCT RECALL"letter dated February 3, 2010, was sent to customers. The letter describes the product, problem and action to be taken by customers. The customers should check their inventory for the affected lot, complete the recall tracking form and return by mail or fax and contact UltiMed for return instructions. If you have any questions concerning this recall, please call UltiMed, Inc. at 877-854-3434 and ask to speak to Jill.
Quantity in Commerce25 units (each dispense and dispose sharps unit contains 100 syringes)
DistributionNationwide distribution: CT and NJ
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = FMF
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