CLASS II Device recall · Reported 28 Mar 2018 · FDA Enforcement Report
Incision & Drainage Tray or Kit recalled by Centurion Medical Products
Centurion Medical Products is recalling Incision & Drainage Tray or 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-1088-2018
- 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
INCISION & DRAINAGE TRAY or 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?
ID1090 ID1485 ID1525 ID1595 ID510 ID525 ID580 ID600 ID800 ID875 ID975 Lot codes: 2015102190 2016010790 2016020890 2016022390 2016061090 2016071990 2016101290 2016110390 2017011990 2016121690 2017022390 2017052690 2015101490 2016060690 2016070890 2016102490 2017032190 2017052390 2015091790 2015111990 2015112590 2016070890 2016072790 2016082390 2017020290 2017032890 2017052690 2017030390 2015092490 2015121490 2016010690 2016033190 2016042790 2016052490 2016061390 2016102790 2016112490 2017042890 2017063090 2017071990 2015100890 2017072890 2017040690 2016092290 2016031790 2016012190 2017030290 2016021890 2016060890 2016070790 2016080590 2016111190 2017010990 2017051190 2015110590 2015103090 2016071490 2015121590 2016031590 2016042090 2016051890 2016052590 2016062190 2016110190 2017010390 2017020890 2017040490 2017060890 2017062890 2017082290 2016112290 2016042790 2017060890 2017070790 2017082490 2015101590 2016022590 2016072890 2016090290 2017011190 2017040690 2017061690 2017081190 2017011690 2015092490 2015100890 2015111990 2016040690 2016060890 2016071890 2017013090 2016030790 2016031590 2016080190 2017010390 2017050490 2016072090 2015081190 2015102790 2016010490 2016022490 2016031190 2016060690 2016082990 2016111790 2017011790 2017032890 2017060790 2017071290 2016011590 2016062390 2016062890
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
All 152| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Centurion Difficult IV KIT containing BD's Vacutainer recalled | Centurion Medical Products | Foreign Material | Nationwide |
| Device | CLASS II | Centurion-Lvad Kits DM1005 Daily Lvad Maintenance Kit recalled | Centurion Medical Products | Sterility | Nationwide |
| 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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| 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 |