CLASS II ONGOING Device recall · Reported 14 Dec 2022 · FDA Enforcement Report
Dover Closed Urethral Tray with Vinyl Catheter/Ch Catheter recalled
Cardinal Health is recalling Dover Closed Urethral Tray with Vinyl Catheter/Ch Catheter Pre-connected to Drainage, distributed nationwide in the US. The recall was initiated on 1 Nov 2022 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-0360-2023
- FDA event ID
- 91087
- Recalling firm
- Cardinal Health, Mansfield, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 Nov 2022
- FDA classified
- 2 Dec 2022
- Reported
- 14 Dec 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 1 Nov 2022 | Recall initiated by company | |
| 2 Dec 2022 | Classified by FDA | +31 days |
| 14 Dec 2022 | 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
Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropriate time, this may increase the risk of urinary retention
Product as listed by the FDA
Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 1000 mL Drainage Bag Product Code: 3450 Intended for urinary drainage from the bladder of a patient
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropriate time, this may increase the risk of urinary retention
Which lots are affected?
UDI-DI: Each 10884521009479 Case 20884521009476 Lot Numbers: 2216502264, 2216507864, 2215825864 2215119164, 2214451964, 2213740964 2213046464, 2212401364, 2212401264 2211101164, 2211101264, 2209515164 2210219664, 2209515264, 2209501064 2207800564, 2208816364, 2207401264 2207401164
Where was it sold?
Nationwide
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
5 other products · FDA event 91087This product is part of a recall event; the main page for the event is Dover Closed Urethral Tray with Vinyl Catheter/Ch Catheter Product recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Dover Closed Urethral Tray with Vinyl Catheter/Ch Catheter Product recalled | Cardinal Health | Other | Nationwide | |
| CLASS II | Dover Closed Urethral Tray with Hydrogel Coated Red Rubber recalled | Cardinal Health | Foreign Material | Nationwide | |
| CLASS II | Dover Closed Urethral Tray with Vinyl Catheter Product recalled | Cardinal Health | Other | Nationwide | |
| CLASS II | Dover Closed Urethral Tray with Vinyl Catheter/Ch Catheter recalled | Cardinal Health | Other | Nationwide | |
| CLASS II | Dover Closed Urethral Tray with Hydrogel Coated Red Rubber recalled | Cardinal Health | Foreign Material | Nationwide |
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|---|---|---|---|---|---|
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| Drug | CLASS II | Recombinate, [Antihemophilic Factor (Recombinant)] vials recalled | Cardinal Health | Manufacturing (CGMP) Deviations | Nationwide |
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| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |