Maintenance Kit PH1 recall
Maintenance Kit PH1, Cod. 6997266 The Phoenix Hemodialysis delivery system is intended to be used to provide high flux and low flux hemodialysis…
Why was Maintenance Kit PH1 recalled?
Baxter Healthcare Corporation is issuing a voluntary product recall for several lots of Phoenix Dialysis Machine Preventive Maintenance Kits due to incorrect silicone straight connectors components packaged in these kits. During Preventive Maintenance, the two silicone connectors must be installed in the Phoenix mass-balance section of hydraulic circuit only if the Phoenix machine has already been modified with "CONN. IMPROVING RETR. KIT" (Code SP00721). Installation of these connectors in machines modified with SP00721 may result in fluid leaks during dialysis treatment. These Preventive Maintenance Kits include the FILTER sub-group, which contains the silicone straight connectors that are larger than expected.
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?
Product code: 6997266; Lot codes: 1607250, 160824D, 161005D, 161026D
- Product
- Maintenance Kit PH1, Cod. 6997266 The Phoenix Hemodialysis delivery system is intended to be used to provide high flux and low flux hemodialysis…
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 211 kits
- Distribution
- Nationwide Distribution
- Recall date
- February 1, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)