Food, drugs, devices › Arrow International Inc
Device recall: PICC Kits with Peel-Away Sheath Component; catheter, intravascular, therapeutic, ultrasound Product Usage: catheter, int
Arrow International Inc (Reading, PA) initiated this device recall on 30 Jul 2015; FDA lists 1 product record under event 71854, classified Class II.
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 28 Jun 2018. Initiation: voluntary: firm initiated. Arrow International Inc has 93 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
Arrow International Inc, Reading, PA.
Reason for recall
"the catheter peel-away component hub tabs may prematurely detach. One injury reported."
Distribution
"US Nationwide Distribution and internationally to Canada"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2462-2015 | PICC Kits with Peel-Away Sheath Component; catheter, intravascular, therapeutic, ultrasound Product Usage: catheter, intravascular, therapeutic, ultrasound | 52109 | Class II | Terminated | 2 Sep 2015 |
Context
Other enforcement events for Arrow International Inc
All 93 events for Arrow International Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "the catheter peel-away component hub tabs may prematurely detach. One injury reported."
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: "US Nationwide Distribution and internationally to Canada"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 28 Jun 2018. "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.