Z-2672-2014Class II

EZ-IO 45mm (40kg & up) Needle Set, part number 9079-VC-005; lot code 3606455

Name: Z-2672-2014 EZ-IO 45mm (40kg & up) Needle Set, part number 9079-VC-005; lot code 3606455
Creator: Vidacare Corporation
Published: 2014-03-31
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2014-03-31 / Terminated / root cause: manufacturing process

FDA source

Vidacare Corporation began a recall of EZ-IO 45mm (40kg & up) Needle Set, part number 9079-VC-005; lot code 3606455 on 2014-03-31. FDA classified it as Class II and gives the reason as "The voluntary recall is due to the needle set not meeting its specifications". 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-2672-2014
Classification: Class II
Status: Terminated
Initiated: 2014-03-31
Posted: 2014-09-22
Terminated: 2015-01-30
Recalling firm: Teleflex Medical
Product: EZ-IO 45mm (40kg & up) Needle Set, part number 9079-VC-005; lot code 3606455
Product code: FMI Needle, Hypodermic, Single Lumen
Reason for recall: The voluntary recall is due to the needle set not meeting its specifications.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: Vidacare sent an Urgent Medical Device Recall Notification to all of its customers on March 31, 2014.The letter identified the product the problem and the action to be taken by the customers. The firm asked its customers to return the affected lot for a replacement. Customers were instructed: 1. If you have affected stock, immediately discontinue use and quarantine any product with the part number and lot number as identified above 2 To return product. complete the enclosed Medical Device Recall Acknowledgment and Return Response Form and fax it to 1 866-431-6194, Attn "Customer Service" This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of product to Vidacare Corporation and to facilitate replacement product if one has not already been provided 3. If you have already used the affected stock. please complete the enclosed Medical Device Recall Acknowledgement and Return Response Form and fax it to 1-866-431- 6194, Attn" Customer Service". This will allow us to document your receipt of the letter. Vidacare Corporation is committed to providing high quality, safe and effective products. We sincerely apologize for any inconvenience this action may cause your operations. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-479-8500.
Quantity in commerce: 172
Distribution: Worldwide Distribution-US (nationwide) including the states of LA, NY, CA, CT, WA, AK, NJ, TX, GA, MI, MO, MD, FL, KY, VA, OH, UT, SC, NC, IN, AZ, MN, IL, TN, OK, KS, NE, MT, MS, AR, ID, WV and PA., and Internationally to Canada
Product codes and lots: Part number 9079-VC-005; lot code 3606455

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2672-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2672-2014	Class II	Terminated	Voluntary: Firm initiated	2014-10-01	2014-09-22

Product code FMI

K052408Class IIEz-IoVidacare Corporation / cleared 2005-11-17

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)