Catalog No — Class II medical device recall Z-0415-2016
Terminated recall by MOOG Medical Devices Group, reported 2015-12-23, distributed in MN. Potential for leaking between the purple ENFit connector and the white transitional stepped connector due to c
| Recall number | Z-0415-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | MOOG Medical Devices Group, Salt Lake City, UT, United States |
| Recall initiated | 2015-11-20 |
| Classified | 2015-12-14 |
| Reported by FDA | 2015-12-23 |
| Terminated | 2016-08-22 |
| Distributed | MN |
| Quantity | 12,014,130 sets |
| Reason classes | packaging |
| Model numbers | 1200ML, GR1200-A, INF0020-A, INF0500-A, INF1200-A |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0415-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.