Recall Z-0415-2016 ยท PIF Gastrointestinal Tubes With Enteral Specific Connectors
MOOG Medical Devices Group
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 Transi
| Date | Nov 20, 2015 |
| Status | Terminated |
| Reason | Potential for leaking between the purple ENFit connector and the white transitional stepped connector due to cracking or breaking of the purple connector. |
| 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 |
| Quantity | 12,014,130 sets |
| Distribution | Distributed to the state of MN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142539 | EnteraLite Infinity Enteral Pump Delivery Set, 1200 mL Enteral Feeding Delivery Set Zevex, Inc., Jan 8, 2015 |