Neomed Inc: NEOCONNECT, Enteral Extension with ENFit connector, REF EXT-60NC The NeoMed NeoConnect Enteral Only Extension Set is intended for use as an extension set for nasogastric/oralgastric or gas

Is my product affected?

NEOCONNECT, Enteral Extension with ENFit connector, REF EXT-60NC The NeoMed NeoConnect Enteral Only Extension Set is intended for use as an extension set for nasogastric/oralgastric or gastric tube enteral feeding tubes, incorporating safety connectors which help mitigate the risk of accidental conn

• UPC 20817584012015
• UPC 10817584012018
• UPC 00817584012011

Check against the official notice below — it lists the full affected range.

What happened

NeoMed Inc. is recalling NeoConnect Enteral Extension sets with ENFit connectors because the sterile pouch labels incorrectly state an expiration date of November 19, 2016, when the correct expiration date is November 9, 2019. The case and shipper labels contain the correct expiration date. A total of 654 boxes containing 32,700 units were distributed across California, Florida, Illinois, Michigan, New Jersey, Ohio, Tennessee, and Texas, all with lot number 20161110.

The recall affects products with specific Universal Device Identifiers listed on the shipper, case, and pouch. The source document does not specify a remedy or what action affected consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

The sterile pouch label states the expiration date is 2016-11-19, but the correct expiration date is 2019-11-09. The case label and the shipper label have the correct date

Details from the source

Reason for recall: The sterile pouch label states the expiration date is 2016-11-19, but the correct expiration date is 2019-11-09. The case label and the shipper label have the correct date Distribution: US Distribution to states of: California, Florida, Illinois, Michigan, New Jersey, Ohio, Tennessee, and Texas. Quantity: 654 boxes (32700 units) Lot/code info: (UDIs) on the shipper [(01)20817584012015 (17)191109 (10)20161110], case [(01)10817584012018 (17)1991109 (10)20161110] and pouch [(01)00817584012011 (17)191109 (10)20161110] Lot Number: 20161110

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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