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Terminated

BE 183 Series Manual Jet Ventilators. Manual Jet Ventilator

FDA Recall Z-0555-04 · Posted 2004-02-27

Recalling FirmInstrumentation Industries Inc
Recall StatusTerminated
Product CodeBTM
Date Initiated2003-09-12
Date Terminated2004-02-26
Product Quantity46 units

Reason for Recall

possible external debris in the on/off plunger.

Firm Action

The recalling firm notified all customers via telephone to inform them of the problem and the need to return the product when received. The recalling firm issued recall letters dated 9/17/03 to their direct accounts informing them of the problem. The also informed the account that a stop shipment had been ordered but if they receive the product they need to return it immediately.

Root Cause

Other

Distribution Pattern

The products were shipped to medical facilities in CA, FL, GA, NY, OH, OR, TX, and UT.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K991785MANUAL JET VENTILATOR (WITH REGULATOR AND GAUGE), MANUAL JET VENTILATOR (WITHOUT REGULATOR AND GAUGE), MODELS BE 183-SURInstrumentation Industries, Inc. · 1999-08-17

Official Source

View FDA Recall →

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

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