Recall Z-0621-2013 ยท BZO Set, Tubing And Support, Ventilator (W Harness)
Fisher & Paykel Healthcare, Ltd.
Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing circuit, 1.8m or 6 feet in length. Oxygen therapy delivery system for adult patient.
| Date | Jan 3, 2013 (initiated Nov 19, 2012) |
| Status | Terminated |
| 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 |
| Root cause | Nonconforming Material/Component |
| Action | Fisher & Paykel sent an Urgent Medical Device Recall letter dated November 19, 2012, with a Product Recall Response Form to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to destroy and discard any affected circuits in their possession. Customers were instructed to complete and return the Product Recall Response form to the address indicated on the form, even if they have no affected product. Customers were asked to forward the recall notice to all those who need to be aware within their organi |
| Quantity | 200 units total, 26 units US |
| Distribution | Worldwide Distribution - USA including IL, IN, AR and GA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.