CLASS II Device recall · Reported 30 Mar 2016 · FDA Enforcement Report
Dover PREM U/M SIL FLY recalled by Covidien
Covidien is recalling Covidien Dover PREM U/M SIL FLY, distributed nationwide in the US. The recall was initiated on 22 Jan 2016 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-1204-2016
- FDA event ID
- 73121
- Recalling firm
- Covidien, North Haven, CT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Jan 2016
- FDA classified
- 21 Mar 2016
- Reported
- 30 Mar 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 22 Jan 2016 | Recall initiated by company | |
| 21 Mar 2016 | Classified by FDA | +59 days |
| 30 Mar 2016 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
Product as listed by the FDA
Covidien Dover PREM U/M 14FR SIL FLY Item Code: P4P14SD P400 Castile soap towelettes are used to clean the genital area for male and female patients
Where it was distributed
US (nationwide) and to Canada.
Questions about this recall
Is Dover PREM U/M SIL FLY recalled?
Yes. Covidien recalled Dover PREM U/M SIL FLY on 22 Jan 2016. The recall is Class II and its status is Terminated. Recall number Z-1204-2016.
Why was it recalled?
Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
Which lots are affected?
Lot Codes: 513256364X 514555864X 516050164X 516852964X 517456764X
Where was it sold?
US (nationwide) and to 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 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.
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