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Open, Classified

Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.

FDA Recall Z-0004-2025 · Posted 2024-10-02

Recalling FirmMercury Enterprises, Inc. dba Mercury Medical
Recall StatusOpen, Classified
Product CodeBTL
Date Initiated2024-08-30
Product Quantity1,300 units

Reason for Recall

Manual resuscitator circuit flow controller may come apart due to a missing manufacturing step.

Firm Action

Mercury Medical notified customers on 09/04/2024 via letter. Consignees who are medical facilities were instructed to immediately review inventory and quarantine any affected units on hand, contact customer service to arrange return of units, and complete the return response form. Consignees who are distributors were instructed to notify customers if further distributed, obtain a response form from those customers, arrange for any return of affected units, and complete the return response form.

Root Cause

Process control

Distribution Pattern

US distribution to MI, FL, SC, PA, IN. International distribution to Albania.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K093913MERCURY MEDICAL T-PIECE RESUSCITATORMercury Medical, Inc. · 2010-04-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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