CLASS II ONGOING Device recall · Reported 18 Jan 2023 · FDA Enforcement Report
Foley Catheter Insertion Tray with preconnected bag recalled
Stradis Healthcare is recalling Foley Catheter Insertion Tray with preconnected bag and catheter, Sterile, distributed nationwide in the US. The recall was initiated on 15 Dec 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-0931-2023
- FDA event ID
- 91350
- Recalling firm
- Stradis Healthcare, Waukegan, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 15 Dec 2022
- FDA classified
- 11 Jan 2023
- Reported
- 18 Jan 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 15 Dec 2022 | Recall initiated by company | |
| 11 Jan 2023 | Classified by FDA | +27 days |
| 18 Jan 2023 | Published in enforcement report | +7 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 the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
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
Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and catheter, Sterile
Where it was distributed
US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.
Nationwide FloridaIllinoisIndianaMassachusettsMississippiNevadaOhioTennesseeTexasWashington
Questions about this recall
Why was it recalled?
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Which lots are affected?
a. Assembly Number 33066, UDI-DI: M752330661, Lot Numbers: 222782334, 222519530, 222438660; b. Assembly Number 33068, UDI-DI: M752330681, Lot Numbers: 222145412, 220551558, 222508466
Where was it sold?
US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.
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
17 other products · FDA event 91350This product is part of a recall event; the main page for the event is McCormick Medical Distribution Port Tray, 25 trays recalled.
More recalls from Stradis Healthcare
All 71| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Hct Central Line Insertion Tray, I recalled by Stradis Healthcare | Stradis Healthcare | Sterility | Nationwide |
| Device | CLASS II | HCT, 2 Port, Sterile, Triple Packaged, 10 EVA BAGS/Pack recalled | Stradis Healthcare | Sterility | Nationwide |
| Device | CLASS II | Tacy Medical, Inc Port Access Tray, Sterile, Qty recalled | Stradis Healthcare | Sterility | Nationwide |
| Device | CLASS II | Picc Kit, 10/cs, Access Medical Label recalled by Stradis Healthcare | Stradis Healthcare | Sterility | Nationwide |
| Device | CLASS II | Henry Shein Cysto Set UP Pack recalled by Stradis Healthcare | Stradis Healthcare | Sterility | Nationwide |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| 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 |