Fisher & Paykel Healthcare reusable breathing circuit. recall
Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing circuit, 1.8m or 6 feet in length. Oxygen therapy delivery system for…
Why was Fisher & Paykel Healthcare reusable breathing circuit. recalled?
FPH has become aware that one batch of tubes supplied to FPH may contain hole damage. These tubes were incorporated by FPH into certain 900MR068 reusable circuits with lot numbers 110810 and 111020. If this hole damage is not detected during the standard leak test before patient use, it could potentially result in a gas leak in the breathing system, which may lead to a loss of pressure for the int
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lots 110810 and 111020
- Product
- Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing circuit, 1.8m or 6 feet in length. Oxygen therapy delivery system for…
- Recalling firm
- Fisher & Paykel Healthcare, Ltd.
- Quantity
- 200 units total, 26 units US
- Distribution
- Worldwide Distribution - USA including IL, IN, AR and GA.
- Recall date
- January 9, 2013
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)