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RT130 and RT131 Neonatal/ Infant Breathing Circuits, heated… recallZ-0553-05 · Fisher & Paykel Healthcare Inc · initiated Dec 21, 2004

Terminated All recalls posted in February 2005

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Fisher & Paykel Healthcare Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Pressure elbow may be partly occluded.

FDA root cause category: Other

What the company is doing

Recall was initiated on 12/17/2004 at all firm locations and distributors worldwide. The recall letter includes instructions for performing a mitigation until new stock is supplied.

Recall details

Recall number
Z-0553-05
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Dec 21, 2004
Posted by the FDA
Feb 18, 2005
Recalling firm
Fisher & Paykel Healthcare Inc
Quantity
2200
Product code
BTT
FDA submissions
K020332
Distribution
Worldwide

Product description

RT130 and RT131 Neonatal/ Infant Breathing Circuits, heated wire. For use with MR850 Respiratory Humidifier.

Code information (models, lots, serial numbers)

Lot umbers in the range 040701 to 041216

Other devices under the same FDA submission

2 devices cleared under K020332 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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