Z-0914-2013Class II

Lifeguard Infusion Set with Smartsite, 20Ga, 1, CLGY-2010 Huber type needle set used for the infusion of...

Name: Z-0914-2013 Lifeguard Infusion Set with Smartsite, 20Ga, 1, CLGY-2010 Huber type needle set used for the infusion of...
Creator: Churchill Medical Systems, Inc.
Published: 2013-01-21
License: https://open.fda.gov/license/

Vygon Mfg / initiated 2013-01-21 / Terminated / root cause: labeling and UDI

FDA source

Churchill Medical Systems, Inc. began a recall of Lifeguard Infusion Set with Smartsite, 20Ga, 1, CLGY-2010 Huber type needle set used for the infusion of medical fluids into implantable ports on 2013-01-21. FDA classified it as Class II and gives the reason as "The label on the device states that the item number is CLGY-2210 when the item number on the device label should read CLGY-2010. This is a 20Ga Huber needle set; however, the product label states the pouch contains a...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0914-2013
Classification: Class II
Status: Terminated
Initiated: 2013-01-21
Posted: 2013-03-06
Terminated: 2013-09-10
Recalling firm: Vygon Mfg
Product: Lifeguard Infusion Set with Smartsite, 20Ga, 1, CLGY-2010 Huber type needle set used for the infusion of medical fluids into implantable ports.
Product code: FPA Set, Administration, Intravascular
Reason for recall: The label on the device states that the item number is CLGY-2210 when the item number on the device label should read CLGY-2010. This is a 20Ga Huber needle set; however, the product label states the pouch contains a 22Ga set.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Vycon sent an Urgent Medical Device Recall letter dated January 21, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed check their stock for the affected product and immediately cease use and distribution and quarantine all affected product immediately. Count and document their affected inventory on the Recall Acknowledgement and Inventory Return Form. Customers were instructed to fax or email the form to Vygon including customer contact information. All affected product would be credited or replaced at no cost to the customer. Customers with questions were instructed to call 1-800-473-5414, or by e-mail at [email protected]. For questions regarding this recall call 603-743-5988.
Quantity in commerce: 2340
Distribution: Nationwide Distribution including MO, IL, FL, PA, VA, MO, NY, NE, NH, and OH.
Product codes and lots: Lot #1210099

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0914-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0914-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-13	2013-03-06

Product code FPA

K013871Class IILifeguard Safety Infusion SetHorizon Medical Products, Inc. / cleared 2002-03-29

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)