Z-0415-2016Class II

Catalog No. INF0020-A EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and...

Name: Z-0415-2016 Catalog No. INF0020-A EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and...
Creator: MOOG Medical Devices Group
Published: 2015-11-20
License: https://open.fda.gov/license/

Zevex, Inc. / initiated 2015-11-20 / Terminated

FDA source

MOOG Medical Devices Group began a recall of Catalog No. INF0020-A EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and Transitional Stepped Connector (spiked set); Catalog No... on 2015-11-20. FDA classified it as Class II and gives the reason as "Potential for leaking between the purple ENFit connector and the white transitional stepped connector due to cracking or breaking of the purple connector". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0415-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-20
Posted: 2015-12-14
Terminated: 2016-08-22
Recalling firm: Zevex, Inc.
Product: Catalog No. INF0020-A EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and Transitional Stepped Connector (spiked set); Catalog No. INF0500-A - 500ml EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and Transitional Stepped Connector; Catalog No INF1200-A - 1200ml EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and Transitional Stepped Connector; Catalog No GR1200-A 1200ml Enteral Feeding Delivery Set with ENFit Connector System and Transitional Stepped Connector (gravity set). Used to dispense liquid nutrients at a preprogrammed pump or user controlled rate.
Product code: PIF Gastrointestinal Tubes With Enteral Specific Connectors
Reason for recall: Potential for leaking between the purple ENFit connector and the white transitional stepped connector due to cracking or breaking of the purple connector.
FDA root cause: Unknown/Undetermined by firm
Action: MOOG Medical sent an URGENT Field Safety Notice, dated November 20, 2015, to its customer. The letter identified the affected device, provided a description of the problem, and discussed the risk to health. The customer was asked to contact all known distributors and inform them that MOOG Medical will cease production of all its enteral administration sets using ENFit connectors and transition back to the previous revision of the product codes that do not include the ENFit connector (INF0020, INF0500, INF1200, and GR1200). MOOG Medical will produce the previous revision until a solution to the problem is found. All necessary users should be made aware of the notice. Christopher Dodge, Manager, Regulatory Affairs, should be contacted with questions or for additional info at 801-264-1001, ext. 112 or [email protected].
Quantity in commerce: 12,014,130 sets
Distribution: Distributed to the state of MN.
Product codes and lots: All EnteraLite Infinity Enteral Pump Delivery Sets with ENFit connector System and transitional Stepped Connector.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0415-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0415-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-23	2015-12-14

Product code PIF

K142539Class IIEnteraLite Infinity Enteral Pump Delivery Set, 1200 mL Enteral Feeding Delivery SetZevex, Inc. / cleared 2015-01-08

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)