Z-1217-2010

Live Better 1cc, 31 gauge x 5/16 inch U-100 Insulin Syringe short needle. 100 syringes, Manufactured by...

Name: Z-1217-2010 Live Better 1cc, 31 gauge x 5/16 inch U-100 Insulin Syringe short needle. 100 syringes, Manufactured by...
Creator: Ulti Med, Inc.
Published: 2010-02-05
License: https://open.fda.gov/license/

Ulti Med, Inc. / initiated 2010-02-05 / Terminated / root cause: manufacturing process

FDA source

Ulti Med, Inc. began a recall of Live 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... on 2010-02-05. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1217-2010
Status: Terminated
Initiated: 2010-02-05
Posted: 2010-03-31
Terminated: 2011-05-07
Recalling firm: Ulti Med, Inc.
Product: Live 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.
Product code: FMF Syringe, Piston
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.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: An " 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 commerce: 25 units (each dispense and dispose sharps unit contains 100 syringes)
Distribution: Nationwide distribution: CT and NJ
Product codes and lots: Lot 171124

Product code FMF

K062702Class IIUlticare Disposable Syringes and NeedlesUltimed, Inc. / cleared 2006-11-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)