CLASS II Device recall · Reported 5 Feb 2014 · FDA Enforcement Report
Port Kit with Access Infusion Set under the following recalled
Navilyst Medical is recalling Port Kit with Access Infusion Set under the following labels: 8F/SL/Plastic Port/F, distributed nationwide in the US. The recall was initiated on 25 Nov 2013 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-0826-2014
- FDA event ID
- 67122
- Recalling firm
- Navilyst Medical, Marlborough, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Nov 2013
- FDA classified
- 24 Jan 2014
- Reported
- 5 Feb 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Heart & Vascular Devices
Timeline
| 25 Nov 2013 | Recall initiated by company | |
| 24 Jan 2014 | Classified by FDA | +60 days |
| 5 Feb 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Navilyst Medical has recalled a Port Kit with Access Infusion Set due to a possible breach of sterilization barrier.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Port Kit with Access Infusion Set under the following labels: 1) 8F/SL/Plastic Port/F, Product Number H965450140, Catalog Number 45-014; 2) 8F/SL/Titanium Ports/NF, Product Number H965450170, Catalog Number 45-017; 3) 6F/SL/Plastic Port/F, Product Number H965450200, Catalog Number 45-020; 4) 8F/SL/Plastic Port/F, Product Number H965450220, Catalog Number 45-022; 5) 8F/SL/Titanium Ports/F, Product Number H965450250, Catalog Number 45-025; 6) Plastic/6F/non-filled/non-valved, Product Number H965450290, Catalog Number 45-029; 7) Plastic/6F/filled/non-valved, Product Number H965450300, Catalog Number 45-030; 8) Plastic/8F/non-filled/non-valved, Product Number H965450310, Catalog Number 45-031; 9) Plastic/8F/filled/non-valved, Product Number H965450320, Catalog Number 45-032; 10) Plastic/6F/non-filled/valved, Product Number H965450370, Catalog Number 45-037; 11) Plastic/6F/filled/valved, Product Number H965450380, Catalog Number 45-038; 12) Plastic/8F/non-filled/valved, Product Number H965450390, Catalog Number 45-039; 13) Plastic/8F/filled/valved, Product Number H965450400, Catalog Number 45-040; 14) Titanium/6F/non-filled/valved, Product Number H965450410, Catalog Number 45-041; 15) Titanium/8F/non-filled/valved, Product Number H965450430, Catalog Number 45-043. Product Usage: ***K-Shield Port Access Infusion Set, (affected product) supplied by Kawasumi Laboratories. The K-Shield Port Access Infusion Set with High Pressure Tubing is an intravascular administration set with a non-coring Huber needle that is used to access an implanted medication port for solution infusion. This device is also indicated for injection of contrast media by a power injector only with power injectable implanted port.***NMI Port is indicated for patients who require 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
US Nationwide Distribution in the states of CA, CT, DC, MA, NJ, NY, PA, MD, VA, WV, NC, GA, FL, TN, OH, MN, MT, IL, MO, NE, OK, TX, NM, and WA.
Nationwide CaliforniaConnecticutDistrict of ColumbiaFloridaGeorgiaIllinoisMassachusettsMarylandMinnesotaMissouriMontanaNorth CarolinaNebraskaNew JerseyNew MexicoNew YorkOhioOklahomaPennsylvaniaTennessee
Questions about this recall
Is Port Kit with Access Infusion Set under the following labels: 8F/SL/Plastic Port/F recalled?
Yes. Navilyst Medical recalled Port Kit with Access Infusion Set under the following labels: 8F/SL/Plastic Port/F on 25 Nov 2013. The recall is Class II and its status is Terminated. Recall number Z-0826-2014.
Why was it recalled?
Navilyst Medical has recalled a Port Kit with Access Infusion Set due to a possible breach of sterilization barrier.
Which lots are affected?
Batch/Lot Numbers: 4688881, 4688883, 4688884, 4688885, 4688887, 4668695, 4654060, 4654060, 4659108, 4668699, 4654061, 4659109, 4668700, 4654062, 4659110, 4668701, 4654063, 4658398, 4662581, 4664985, 4675021, 4681156, 4654064, 4654065, 4658399, 4658400, 4662583 and 4675023
Where was it sold?
US Nationwide Distribution in the states of CA, CT, DC, MA, NJ, NY, PA, MD, VA, WV, NC, GA, FL, TN, OH, MN, MT, IL, MO, NE, OK, TX, NM, and WA.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Navilyst Medical
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|---|---|---|---|---|---|
| Device | CLASS II | Namic Convenience Kit, Radiology Kit, Upn H749601014911 recalled | Navilyst Medical | Sterility | Nationwide |
| Device | CLASS II | Namic Convenience Kit, Left Heart Kit, Upn H749601113111 recalled | Navilyst Medical | Sterility | Nationwide |
| Device | CLASS II | Namic Convenience Kit, Left Heart Cath Kit, Upn H7496010018151 recalled | Navilyst Medical | Sterility | Nationwide |
| Device | CLASS II | Namic Convenience Kit, Left Heart Kit, Upn H9656002072121 recalled | Navilyst Medical | Sterility | Nationwide |
| Device | CLASS II | Namic Convenience Kit, UPN H965601206511 recalled by Navilyst Medical | Navilyst Medical | Sterility | Nationwide |
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