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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81116

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
June 04, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Neomed Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

NeoMed Enteral Feeding Tubes with Enteral Only Connectors, French sizes 4.0Fr, 5.0Fr, 6.5Fr, 8.0Fr, and lengths 40cm, 60cm, 90cm. The product consists of a polyurethane feeding tube with an attached hub and tethered plug to close the hub when the feeding tube is not in use. Product Usage: Intended for use in neonatal and pediatric patients to provide nutrition via nasal or oral gastric placement and is not intended for use beyond 30 days.

Z-0093-2019
Recall number
Z-0093-2019
Initiated
June 04, 2018
Classification
Class II
Status
Terminated
Recalling firm
Neomed Inc
Quantity
208,260 units (20,826 cases)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the tethered plug on the hub of the NeoMed Enteral Feeding Tubes with Enteral Only Connectors to inadvertently open after closure.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

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Inspect official wording and provenance

Reason for recall

Potential for the tethered plug on the hub of the NeoMed Enteral Feeding Tubes with Enteral Only Connectors to inadvertently open after closure.

Code information

Model Number (Lot Numbers): FTS5.0P EO (20170731, 20170804, 20170813, 20170914, 20171011, 20171018, 20171128, 20180108, 20180125); FTM5.0P EO (20170818, 20170904, 20170915, 20171009, 20171130, 20171204, 20171227, 20180205, 20180317); FTL5.0P EO (20170816, 20170904, 20171204, 20180115); FTS6.5P EO (20170830, 20170918, 20171019, 20171122, 20171214, 20171216, 20180122, 20180208, 20181113); FTM6.5P EO (20170906, 20171020, 20171202, 20171219, 20180111, 20180208, 20180303, 20180320); FTL6.5P EO (20170708, 20171209, 20180113, 20180122, 20180309, 20180323); FTS8.0P EO (20170825, 20171207, 20171230, 20180103, 20180325); FTM8.0P EO (20171115, 20171222, 20180129); FTL8.0P EO (20170719, 20170721, 20171114, 20180116, 20180202, 20180422); PFTL5.0P EO (20171124); PFTM6.5P EO (20171121); PFTL6.5P EO (20170819, 20171120); PFTM8.0P EO (20170906, 20170919, 20171116); PFTL8.0P EO (20170919, 20171006, 20171118);

Distribution pattern

Worldwide Distribution - US Nationwide in the states of: Alaska, Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, and Wyoming. Worldwide distribution to Australia, Canada, Singapore, and Spain.

Field note

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