Z-0679-2018Class II

20Ga x .75 LifeGuard Huber Needle with Y-site

Name: Z-0679-2018 20Ga x .75 LifeGuard Huber Needle with Y-site
Creator: Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
Published: 2017-07-24
License: https://open.fda.gov/license/

Vygon Mfg / initiated 2017-07-24 / Terminated / root cause: packaging

FDA source

Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. began a recall of 20Ga x .75 LifeGuard Huber Needle with Y-site. Product Code: CLGY-2034 on 2017-07-24. FDA classified it as Class II and gives the reason as "Vygon is conducting a voluntary recall of the products and lots listed in this recall, being initiated because our Tyvek supplier has notified Vygon of issues with their product, specifically the Tyvek may not be coated...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0679-2018
Classification: Class II
Status: Terminated
Initiated: 2017-07-24
Posted: 2018-02-21
Terminated: 2019-11-07
Recalling firm: Vygon Mfg
Product: 20Ga x .75 LifeGuard Huber Needle with Y-site. Product Code: CLGY-2034.
Product code: FPA Set, Administration, Intravascular
Reason for recall: Vygon is conducting a voluntary recall of the products and lots listed in this recall, being initiated because our Tyvek supplier has notified Vygon of issues with their product, specifically the Tyvek may not be coated completely causing gaps in the adhesive used to seal the product packaging. This potential lack of adhesive may affect the sterility of the product.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: Vygon sent recall letters dated July 24, 2017, to customers via email and fax with read receipts and delivery confirmations. The recall letter informed customers of the reason for recall, product description, code and lot number, and instructions to customers, with a Recall Acknowledgement and Inventory Return Form provided/accompanying the recall letter.
Quantity in commerce: 396 units
Distribution: U.S.
Product codes and lots: Lot Number: 1706017D

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0679-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0678-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-28	2018-02-21
Z-0679-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-28	2018-02-21
Z-0680-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-28	2018-02-21
Z-0681-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-28	2018-02-21
Z-0682-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-28	2018-02-21

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)