CLASS II Device recall · Reported 27 Nov 2019 · FDA Enforcement Report
Xcela, 8f Single Plastic Port Filled, Valved, Upn H965440400 recalled
Angiodynamics Inc. (Navilyst Medical Inc.) is recalling Xcela, 8f Single Plastic Port Filled, Valved, Upn H965440400, distributed nationwide in the US. The recall was initiated on 18 Sep 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0505-2020
- FDA event ID
- 83907
- Recalling firm
- Angiodynamics Inc. (Navilyst Medical Inc.), Glens Falls, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Sep 2019
- FDA classified
- 21 Nov 2019
- Reported
- 27 Nov 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 18 Sep 2019 | Recall initiated by company | |
| 21 Nov 2019 | Classified by FDA | +64 days |
| 27 Nov 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Snap lock connectors provided within implantable port kits may not meet dimensional specifications, and the catheter cannot be inserted into the snap lock connector prior to connection to the port chamber, resulting in a delay to the implantation procedure.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
XCELA, 8F SINGLE PLASTIC PORT FILLED, VALVED, UPN H965440400, Cat. No. 44-040 - Product Usage: Long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products. The device is also indicated for blood specimen withdrawal.
Where it was distributed
Worldwide distribution - US Nationwide in the state of CA, CT, FL, GA, IA, IN, KS, KY, MI, MO, MS, MT, NE, NJ, NY, OH, OK, OR, PA, TN, TX, WA, WI and country of Canada.
Nationwide CaliforniaConnecticutFloridaGeorgiaIowaIndianaKansasKentuckyMichiganMissouriMississippiMontanaNebraskaNew JerseyNew YorkOhioOklahomaOregonPennsylvaniaTennessee
Questions about this recall
Why was it recalled?
Snap lock connectors provided within implantable port kits may not meet dimensional specifications, and the catheter cannot be inserted into the snap lock connector prior to connection to the port chamber, resulting in a delay to the implantation procedure.
Which lots are affected?
5480564
Where was it sold?
Worldwide distribution - US Nationwide in the state of CA, CT, FL, GA, IA, IN, KS, KY, MI, MO, MS, MT, NE, NJ, NY, OH, OK, OR, PA, TN, TX, WA, WI and country of Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 83907This product is part of a recall event; the main page for the event is Bioflo 8f Single Titanium Non- Filled recalled.
More recalls from Angiodynamics Inc. (Navilyst Medical Inc.)
All 78| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Xcela PICC with Pasv Valve Technology/Kit 5 F recalled | Angiodynamics Inc. (Navilyst Medical Inc.) | Labeling Errors | NY |
| Device | CLASS II | Smart Port CT-Implantable Port recalled by Angiodynamics Inc. (Navilyst | Angiodynamics Inc. (Navilyst Medical Inc.) | Sterility | Nationwide |
| Device | CLASS II | AngioDynamics Safe Sheath Ultralite recalled | Angiodynamics Inc. (Navilyst Medical Inc.) | Sterility | Nationwide |
| Device | CLASS II | Starburst Talon Semi-Flex Electrosurgical Device recalled | Angiodynamics Inc. (Navilyst Medical Inc.) | Labeling Errors | 5 states |
| Device | CLASS II | Bioflo 8f Single Plastic Non-filled recalled | Angiodynamics Inc. (Navilyst Medical Inc.) | Device Malfunction | Nationwide |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |