CLASS II Device recall · Reported 28 Mar 2018 · FDA Enforcement Report
Tubing Change Kit recalled by Centurion Medical Products
Centurion Medical Products is recalling Tubing Change Kit, distributed nationwide in the US. The recall was initiated on 23 Oct 2017 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-1086-2018
- FDA event ID
- 79329
- Recalling firm
- Centurion Medical Products, Williamston, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Oct 2017
- FDA classified
- 17 Mar 2018
- Reported
- 28 Mar 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Other Medical Devices
Timeline
| 23 Oct 2017 | Recall initiated by company | |
| 17 Mar 2018 | Classified by FDA | +145 days |
| 28 Mar 2018 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine assay level required to support the 36 month shelf life.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
TUBING CHANGE KIT
Where it was distributed
Nationally
Questions about this recall
Why was it recalled?
Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine assay level required to support the 36 month shelf life.
Which lots are affected?
DT6870 Lot codes: 2015110290 2016090890 2017042690
Where was it sold?
Nationally
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
20 other products · FDA event 79329This product is part of a recall event; the main page for the event is Neonatal Iv Access Set recalled by Centurion Medical Products.
More recalls from Centurion Medical Products
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|---|---|---|---|---|---|
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| Device | CLASS II | Centurion- Pelvic Exam Kits DYNDE1037 Pelvic Exam recalled | Centurion Medical Products | Sterility | Nationwide |
| Device | CLASS II | Centurion- SPEC0002B Arthrogram Tray SPEC0002B Arthrogram recalled | Centurion Medical Products | Sterility | Nationwide |
| Device | CLASS II | Centurion-Irrigation Kit IG25STSS Irrigation Gun &Valve Set recalled | Centurion Medical Products | Sterility | Nationwide |
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