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Terminated

VORTRAN Automatic Resuscitator, VARPlus; Model PTE-5002; Qty: 10 each Anesthesiology: This device is to be used by properly trained personnel to deliver emergency, short term, constant flow, pressure cycled ventilatory support.

FDA Recall Z-2091-2017 · Posted 2017-04-25

Recalling FirmVortran Medical Technology 1, Inc
Recall StatusTerminated
Product CodeBTL
Date Initiated2017-04-20
Date Terminated2017-10-17
Product Quantity35 cases (10 each)

Reason for Recall

Vortran received a customer complaint that the spin-nut-DSS connector was assembled in the reverse direction on the oxygen tubing; making the connector unable to be screwed on due to the wrong thread direction.

Firm Action

Medical Device Recall letters were sent on April 20, 2017. Letters explained the reason for recall and listed the specific lots sent to each distributor along with dates, PO numbers and quantity. Vortran Medical asks that each distributor provide a list of customers who received the affected product so that they can notify them directly of the recall.

Root Cause

Process control

Distribution Pattern

CA, MS, FL

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041473VAR-PLUS (VORTRAN AUTOMATIC RESUSCITATOR), MODEL PCMVortran Medical Technology 1, Inc. · 2004-07-15K001430RESPIRTECH PRO-O2C, MODEL 2200 AND RESPIRTECH PRO, MODEL 2000Vortran Medical Technology 1, Inc. · 2000-07-05K973975RESPIRTECHPROVortran Medical Technology 1, Inc. · 1998-06-12

Official Source

View FDA Recall →

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

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