Food, drugs, devices › Bard Access Systems Inc.
Device recall: StatLock¿ IV Premium Catheter Stabilization Device, product code IV0570. sterile. Packaging: packaged as single units in
FDA enforcement event 77132 is a device recall by Bard Access Systems Inc. of Salt Lake City, UT, initiated 25 Apr 2017 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. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 21 Aug 2017. Initiation: voluntary: firm initiated. Bard Access Systems Inc. has 10 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
Bard Access Systems Inc., Salt Lake City, UT.
Reason for recall
"StatLockTM IV Premium Catheter Stabilization Device may contain an incorrectly sized retainer clip."
Distribution
"Nationwide Distribution - Internationally to Canada. No govt/VA/Military consignees."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2120-2017 | StatLock¿ IV Premium Catheter Stabilization Device, product code IV0570. sterile. Packaging: packaged as single units in tyvek to film pouches, the product is distributed in cartons containing 25 devices and cases containing 250 devices. | 4,500 units | Class II | Terminated | 31 May 2017 |
Context
Other enforcement events for Bard Access Systems Inc.
All 10 events for Bard Access Systems Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "StatLockTM IV Premium Catheter Stabilization Device may contain an incorrectly sized retainer clip."
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: "Nationwide Distribution - Internationally to Canada. No govt/VA/Military consignees."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 21 Aug 2017. "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.