CLASS II Device recall · Reported 10 Feb 2016 · FDA Enforcement Report
Baxter, Rapidfill Syringe Strip For use recalled
Baxter Corporation Englewood is recalling Baxter, Rapidfill Syringe Strip For use with Rapidfill Automated Syringe Filler (Asf), distributed nationwide in the US. The recall was initiated on 21 Dec 2015 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-0731-2016
- FDA event ID
- 72946
- Recalling firm
- Baxter Corporation Englewood, Englewood, CO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Dec 2015
- FDA classified
- 30 Jan 2016
- Reported
- 10 Feb 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Syringes & Needles
Timeline
| 21 Dec 2015 | Recall initiated by company | |
| 30 Jan 2016 | Classified by FDA | +40 days |
| 10 Feb 2016 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
All lots of RAPIDFILL Syringe Strips lack evidence supporting the packaging claim for 12-month shelf life on released product.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Baxter, RAPIDFILL Syringe Strip, 10 ml. For use with RAPIDFILL Automated Syringe Filler (ASF)
Where it was distributed
Worldwide Distribution-US (nationwide) and the countries of Canada, Sweden, Germany, and the Netherlands.
Questions about this recall
Why was it recalled?
All lots of RAPIDFILL Syringe Strips lack evidence supporting the packaging claim for 12-month shelf life on released product.
Which lots are affected?
All Lots
Where was it sold?
Worldwide Distribution-US (nationwide) and the countries of Canada, Sweden, Germany, and the Netherlands.
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.
More recalls from Baxter Corporation Englewood
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | 0.2 Micron Filter recalled by Baxter Corporation Englewood | Baxter Corporation Englewood | Particulate Matter | Nationwide |
| Device | CLASS II | Abacus SE (Single-Workstation Edition) and Abacus ME recalled | Baxter Corporation Englewood | Device Malfunction | Nationwide |
| Device | CLASS II | Baxter, Self-Righting Syringe Tip Caps recalled | Baxter Corporation Englewood | Other | Nationwide |
| Device | CLASS II | Self-Righting Luer Lock Tip Cap, Green recalled | Baxter Corporation Englewood | Foreign Material | 4 states |
| Device | CLASS II | Abacus 3.1, Pharmacy Calculator recalled by Baxter Corporation Englewood | Baxter Corporation Englewood | Device Malfunction | Nationwide |
Other Syringes & Needles recalls
All 1,069| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Vacuette LH Lithium Heparin Separator recalled | Greiner Bio-One North America | Other | Nationwide |
| Device | CLASS II | Medtronic Biopsy Needle Kit recalled by Medtronic Navigation | Medtronic Navigation | Sterility | 44 states |
| Device | CLASS II | Williams Cystoscopic Injection Needles, used recalled by Cook | Cook | Device Malfunction | 5 states |
| Device | CLASS II | Embosphere 500-700 micrometer Syringe Sterile Steam recalled | Merit Medical Systems | Sterility | Nationwide |
| Device | CLASS II | IV Sets with drip chambers recalled by ICU Medical | ICU Medical | Particulate Matter | Nationwide |