Food, drugs, devices › Baxter Corporation Englewood
Device recall: Baxter, RAPIDFILL Syringe Strip, 10 ml. For use with RAPIDFILL Automated Syringe Filler (ASF)
FDA enforcement event 72946 is a device recall by Baxter Corporation Englewood of Englewood, CO, initiated 21 Dec 2015 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,153 device enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 18 Aug 2016. Initiation: voluntary: firm initiated. Baxter Corporation Englewood has 9 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Baxter Corporation Englewood, Englewood, CO.
Reason for recall
"All lots of RAPIDFILL Syringe Strips lack evidence supporting the packaging claim for 12-month shelf life on released product."
Distribution
"Worldwide Distribution-US (nationwide) and the countries of Canada, Sweden, Germany, and the Netherlands."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0731-2016 | Baxter, RAPIDFILL Syringe Strip, 10 ml. For use with RAPIDFILL Automated Syringe Filler (ASF) | 4,695 | Class II | Terminated | 10 Feb 2016 |
Context
Other enforcement events for Baxter Corporation Englewood
All 9 events for Baxter Corporation Englewood
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "All lots of RAPIDFILL Syringe Strips lack evidence supporting the packaging claim for 12-month shelf life on released product."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution-US (nationwide) and the countries of Canada, Sweden, Germany, and the Netherlands."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 18 Aug 2016. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.