CLASS II Device recall · Reported 14 Aug 2019 · FDA Enforcement Report
Sterile Fluoro Ssp Tray Kit recalled by Centurion Medical Products
Centurion Medical Products is recalling Sterile Fluoro Ssp Tray Kit, distributed nationwide in the US. The recall was initiated on 1 Jul 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-2162-2019
- FDA event ID
- 83329
- Recalling firm
- Centurion Medical Products, Williamston, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Jul 2019
- FDA classified
- 6 Aug 2019
- Reported
- 14 Aug 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Test Kits & Diagnostics
Timeline
| 1 Jul 2019 | Recall initiated by company | |
| 6 Aug 2019 | Classified by FDA | +36 days |
| 14 Aug 2019 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for sterile packaging to be compromised
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
STERILE FLUORO SSP TRAY Kit Code: MNS11605 - Product Usage: This kit is used for arthrogram injection and aspiration. The kits are used in the diagnostic section of the radiology department, by medical professionals in a clinical setting.
Where it was distributed
US Nationwide distribution in the states of AZ, CA, FL, GA, IL, KY, MA, MD, MI, NC, NH, NY, OH, SC, TX, TN, VA, WA, WI.
Nationwide ArizonaCaliforniaFloridaGeorgiaIllinoisKentuckyMassachusettsMarylandMichiganNorth CarolinaNew HampshireNew YorkOhioSouth CarolinaTennesseeTexasVirginiaWashingtonWisconsin
Questions about this recall
Why was it recalled?
Potential for sterile packaging to be compromised
Which lots are affected?
Lot # 2019020590 Exp : 8/31/2020
Where was it sold?
US Nationwide distribution in the states of AZ, CA, FL, GA, IL, KY, MA, MD, MI, NC, NH, NY, OH, SC, TX, TN, VA, WA, WI.
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
12 other products · FDA event 83329This product is part of a recall event; the main page for the event is Driveline Management System 1 Daily Kit recalled.
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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