CLASS II ONGOING Device recall · Reported 13 Apr 2022 · FDA Enforcement Report
Surgicare Neuro Pack - Neurological Kit recalled by Stradis Medical
Stradis Medical is recalling Surgicare Neuro Pack - Neurological Kit, distributed nationwide in the US. The recall was initiated on 25 Feb 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-0862-2022
- FDA event ID
- 89671
- Recalling firm
- Stradis Medical, Peachtree Corners, GA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 25 Feb 2022
- FDA classified
- 4 Apr 2022
- Reported
- 13 Apr 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 25 Feb 2022 | Recall initiated by company | |
| 4 Apr 2022 | Classified by FDA | +38 days |
| 13 Apr 2022 | 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
The outer bag may be perforated or torn, 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
Surgicare Neuro Pack - Neurological Kit
Where it was distributed
US Nationwide distribution in the states of IN, TX, and PA.
Questions about this recall
Why was it recalled?
The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.
Which lots are affected?
SKU/Part Number 570-2224; UDI H65257022240 Lot Numbers: 20143461101, 20156461682, 20217462972, 20309467143, 20343467142, 20364467508, 20364468264, 21076471300, 21082471463, 21102472013, 21117472929, 21126473545
Where was it sold?
US Nationwide distribution in the states of IN, TX, and PA.
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
4 other products · FDA event 89671This product is part of a recall event; the main page for the event is Coryell Memorial Hosp Total, Joint Pack - Surgical Kit recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Coryell Memorial Hosp Total, Joint Pack - Surgical Kit recalled | Stradis Medical | Sterility | Nationwide | |
| CLASS II | Anterior Hip Pack - Surgical Kit recalled by Stradis Medical | Stradis Medical | Sterility | Nationwide | |
| CLASS II | Total Knee Pack - Surgical Kit recalled by Stradis Medical | Stradis Medical | Sterility | Nationwide | |
| CLASS II | Lum Lam Custom Pack - Anesthesia Kit recalled by Stradis Medical | Stradis Medical | Sterility | Nationwide |
More recalls from Stradis Medical
All 93| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Henry Schein, Ilr Insertion Tray recalled by Stradis Medical | Stradis Medical | Sterility | Nationwide |
| Device | CLASS II | Henry Schein, Breast Pack recalled by Stradis Medical | Stradis Medical | Sterility | Nationwide |
| Device | CLASS II | Stradis Healthcare, Custom Pack recalled by Stradis Medical | Stradis Medical | Sterility | Nationwide |
| Device | CLASS II | Stradis Healthcare, Safety Pins, Small 1" recalled by Stradis Medical | Stradis Medical | Sterility | Nationwide |
| Device | CLASS II | Stradis Healthcare, Probe Cover W/gel Pack recalled by Stradis Medical | Stradis Medical | Sterility | Nationwide |
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|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| 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 |