CLASS II Device recall · Reported 24 Jun 2020 · FDA Enforcement Report
Regard SRHS Central Line Kit, Sterile recalled
Resource Optimization & Innovation is recalling Regard SRHS Central Line Kit, Sterile, distributed nationwide in the US. The recall was initiated on 4 May 2020 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-2369-2020
- FDA event ID
- 85632
- Recalling firm
- Resource Optimization & Innovation, Saint Louis, MO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 May 2020
- FDA classified
- 15 Jun 2020
- Reported
- 24 Jun 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 4 May 2020 | Recall initiated by company | |
| 15 Jun 2020 | Classified by FDA | +42 days |
| 24 Jun 2020 | 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
There is a potential for the product to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field.
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
Regard SRHS Central Line Kit, Sterile, 20/case - Product Usage: The Saline Flush Syringes are intended to be used only for the flushing of indwelling of vascular access devices.
Where it was distributed
US Nationwide distribution including in the states of MO, NC.
Questions about this recall
Why was it recalled?
There is a potential for the product to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field.
Which lots are affected?
Item number 303399REG: lot numbers: 257967, 259035, 260742, 259418, 261252, 261888, 263836, 264669, 268918, 271005, 265730, 270198, and 270567.
Where was it sold?
US Nationwide distribution including in the states of MO, NC.
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
1 other product · FDA event 85632| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Regard SRHS GIC Port A Cath, Sterile, Qty recalled | Resource Optimization & Innovation | Sterility | Nationwide |
More recalls from Resource Optimization & Innovation
All 228| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Regard IV Start Kit for preparing and/or dressing recalled | Resource Optimization & Innovation | Other | MO |
| Device | CLASS II | regard Migrating Indicator, Steam Migrating Indicator Strips recalled | Resource Optimization & Innovation | Device Malfunction | Nationwide |
| Device | CLASS II | Regard SRHS GIC Port A Cath, Sterile, Qty recalled | Resource Optimization & Innovation | Sterility | Nationwide |
| Device | CLASS II | Regard Custom Surgical Pack Packs contain surgical recalled | Resource Optimization & Innovation | Labeling Errors | TX |
| Device | CLASS II | Regard, Item Number: 800558001, Sterile, OR0647A - Extremity recalled | Resource Optimization & Innovation | Sterility | LA, TX |
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| Device | CLASS II | TufTex¿ Over-the-Wire Embolectomy Catheter recalled | LeMaitre Vascular | Other | Nationwide |
| Device | CLASS II | Endovascular Pack kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Bard Ep Xt Decapolar Steerable, Diagnostic Ep Catheter, 6f recalled | Stryker Sustainability Solutions | Particulate Matter | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |