CLASS II Device recall · Reported 20 May 2020 · FDA Enforcement Report
BD PosiFlush SF Saline Flush Syringe used in Powerwand XL Quick Kit recalled
Access Scientific is recalling BD PosiFlush SF Saline Flush Syringe used in Powerwand XL Quick Kit, distributed nationwide in the US. The recall was initiated on 23 Apr 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-1980-2020
- FDA event ID
- 85586
- Recalling firm
- Access Scientific, San Diego, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Apr 2020
- FDA classified
- 14 May 2020
- Reported
- 20 May 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 23 Apr 2020 | Recall initiated by company | |
| 14 May 2020 | Classified by FDA | +21 days |
| 20 May 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Saline Flush Syringe compromised sterility due to holes in the packaging.
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
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 3Fr 6cm Quick Kit. REF/UDI / 94123/10859821006473 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast media up to a rate of 8 ml/sec and at a maximum of 325 psi fluid pressure.
Where it was distributed
US Nationwide distribution including in the states of AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, WA.
Nationwide ArkansasArizonaCaliforniaColoradoConnecticutFloridaGeorgiaIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMaineMichiganMinnesotaMissouriMississippi
Questions about this recall
Is BD PosiFlush SF Saline Flush Syringe used in Powerwand XL Quick Kit recalled?
Yes. Access Scientific recalled BD PosiFlush SF Saline Flush Syringe used in Powerwand XL Quick Kit on 23 Apr 2020. The recall is Class II and its status is Terminated. Recall number Z-1980-2020.
Why was it recalled?
Saline Flush Syringe compromised sterility due to holes in the packaging.
Which lots are affected?
LOTS:257866, 259929, 260815, 260982, 264749, 267192, 267193, 269120
Where was it sold?
US Nationwide distribution including in the states of AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, 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 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.
More recalls from Access Scientific
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS III | Powerwand XL Maximum Barrier Kit (Introducer recalled | Access Scientific | Labeling Errors | Nationwide |
| Device | CLASS II | BD PosiFlush SF Saline Flush Syringe used recalled by Access Scientific | Access Scientific | Sterility | Nationwide |
| Device | CLASS II | BD PosiFlush SF Saline Flush Syringe used recalled by Access Scientific | Access Scientific | Sterility | Nationwide |
| Device | CLASS II | BD PosiFlush SF Saline Flush Syringe used in Powerwand XL Quick Kit recalled | Access Scientific | Sterility | Nationwide |
| Device | CLASS II | BD PosiFlush SF Saline Flush Syringe used in Powerwand XL Quick Kit recalled | Access Scientific | 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 |