Food, drugs, devices › Baxa Corporation
Device recall: Baxa Vial Adapter, 14mm - Luer Lock, Order No. REF: 90, Quantity: 50 each, Single Use. Product Code H93890. Used as a ne
FDA enforcement event 66082 is a device recall by Baxa Corporation of Englewood, CO, initiated 22 Aug 2013 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. 90% of the 1,236 device enforcement events initiated in 2013 carry the same class.
Status: Terminated, terminated 19 Aug 2016. Initiation: voluntary: firm initiated. Baxa Corporation has 3 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
Baxa Corporation, Englewood, CO.
Reason for recall
"Baxter Healthcare Corporation is voluntarily recalling one lot of Baxa Vial Adapters, 14mm - Luer Lock, due to incorrect expiry date."
Distribution
"Distributed to One Customer in NC."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2165-2013 | Baxa Vial Adapter, 14mm - Luer Lock, Order No. REF: 90, Quantity: 50 each, Single Use. Product Code H93890. Used as a needleless access device for reconstitution and drug transfer. | 34 cases | Class II | Terminated | 18 Sep 2013 |
Context
Other enforcement events for Baxa Corporation
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 4 Jun 2013 | ExactaMix 1200 and 2400 Compounders. Used as an automated pumping system that compounds multiple sterile ingredients int | Device | Class II | 1 |
| 3 Oct 2012 | Repeater Pump, Class II device used for facilitating repeatable drug dosage distribution and reconstitution in hospital | Device | Class II | 1 |
All 3 events for Baxa Corporation
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Baxter Healthcare Corporation is voluntarily recalling one lot of Baxa Vial Adapters, 14mm - Luer Lock, due to incorrect expiry date."
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: "Distributed to One Customer in NC."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 19 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.