Recall Z-0621-2013— Fisher & Paykel Healthcare, Ltd.
Class I · Terminated
Class I FDA medical device recall by Fisher & Paykel Healthcare, Ltd., initiated 2012-11-19, terminated 2013-07-11. FDA's recall record names no specific 510(k) clearance for this event. Product: Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing circuit, 1.8m or 6 feet in length. Oxygen therapy delivery system for adult patient.. Reason: 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.
- Recalling firm
- Fisher & Paykel Healthcare, Ltd.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2012-11-19
- Terminated
- 2013-07-11
- Firm location
- North Shore City, N/A, New Zealand
Product description
Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing circuit, 1.8m or 6 feet in length. Oxygen therapy delivery system for adult patient.
Reason for recall
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
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