Food, drugs, devices › Cook Inc.
Device recall: Ring Transjugular Intrahepatic Access Set Product Usage: The Ring Transjugular Intrahepatic Access Sets are intended for
Cook Inc. (Bloomington, IN) initiated this device recall on 28 May 2015; FDA lists 2 product records under event 71430, 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 30 May 2017. Initiation: voluntary: firm initiated. Cook Inc. has 61 enforcement events on this register, with a median of 2 product records 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
Cook Inc., Bloomington, IN.
Reason for recall
"Cook Inc. is initiating a voluntary recall of the Ring Transjugular Intrahepatic Access Set and the Flexor RTPS Introduce Sheath due to complaints of the dilators being too long."
Distribution
"Worldwide Distribution - US Nationwide in the state of: AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NM, NV, NY, OH, OK, PA, SD, TN, TX, UT, VA, WA, WI, WV and…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2100-2015 | Ring Transjugular Intrahepatic Access Set Product Usage: The Ring Transjugular Intrahepatic Access Sets are intended for transjugular liver access in diagnostic and interventional procedures. The Ring Transjugular Intrahepatic Access Set consists of the following components: Flexor RTPS Guiding Sheath, needle,… | 661 | Class II | Terminated | 29 Jul 2015 |
| Z-2101-2015 | Flexor RTPS Guiding Sheath Product Usage: The Flexor RTPS Guiding Sheaths are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional devices. These curved sheaths are manufactured from material incorporating a stainless steel wire imbedded in the sheath… | 661 | Class II | Terminated | 29 Jul 2015 |
Context
Other enforcement events for Cook Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Cook Inc. is initiating a voluntary recall of the Ring Transjugular Intrahepatic Access Set and the Flexor RTPS Introduce Sheath due to complaints of the dilators being too long."
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 in the state of: AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NM, NV, NY, OH, OK, PA, SD, TN, TX, UT, VA, WA, WI, WV and…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 30 May 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.