Device recall: Bentson PTFE Wire Guide, Guidewire, Global Product Number G14589, G14590
Class II FDA enforcement event 82026. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
Class II, in the words of FDA
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
Cook Inc. started this device recall on 4 Jan 2019. The firm address in the FDA record is in Bloomington, IN. FDA put the recall in Class II. FDA event 82026 has 20 product records. The first FDA enforcement report date is 12 Feb 2020. The record gives the status Terminated, with the termination date 29 May 2020.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Domestic distribution to nationwide US. Foreign distribution to Australia, Belgium, Bolivia, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, France, French…
Recalling firm
Cook Inc., Bloomington, IN.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
20 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0959-2020 | Bentson PTFE Wire Guide, Guidewire, Global Product Number G14589, G14590 | 1079 | Class II | Terminated | 12 Feb 2020 |
| Z-0960-2020 | Fixed Core Straight Safety Wire Guide, Guidewire, Global Product Number G14285 | 15 | Class II | Terminated | 12 Feb 2020 |
| Z-0961-2020 | Heavy Duty PTFE Wire Guide, Guidewire, Global Product Number G14323 G14260 G14260 | 146 | Class II | Terminated | 12 Feb 2020 |
| Z-0962-2020 | PTFE Wire Guide, Guidewire, Global Product Number 638813 635413-10 | 3929 | Class II | Terminated | 12 Feb 2020 |
| Z-0963-2020 | Roadrunner Hydrophilic PC Wire Guide, Guidewire, Global Product Number G18629, G17866 | 13388 total | Class II | Terminated | 12 Feb 2020 |
| Z-0964-2020 | Wire Guide, Guidewire, Global Product Number G14326 | 13388 total | Class II | Terminated | 12 Feb 2020 |
| Z-0965-2020 | Angled Tip Ureteral Catheter Set, Ureteral Catheter, Global Product No. G14598 | 13388 total | Class II | Terminated | 12 Feb 2020 |
| Z-0966-2020 | Angled Tip Ureteral Catheter Set with Bentson PTFE Wire Guide, Ureteral Catheter, Global Product No. G19108 G14587 G15302 G14326 | 13388 total | Class II | Terminated | 12 Feb 2020 |
| Z-0967-2020 | Percutaneous Entry Set, Nephrostomy Catheter, Global Product No. G14649 | 13388 total | Class II | Terminated | 12 Feb 2020 |
| Z-0968-2020 | Percutaneous Malecot Nephrostomy Set, Global Product No. G16714 G19107 G19108 | 13388 total | Class II | Terminated | 12 Feb 2020 |
| Z-0969-2020 | Percutaneous Pigtail Nephrostomy Set , Global Product No. G14094 G14095 G14899 G14329 | 13388 total | Class II | Terminated | 12 Feb 2020 |
| Z-0970-2020 | Urethral Dilation Balloon Catheter with Open Tip , Global Product No. G17844 | 13388 total | Class II | Terminated | 12 Feb 2020 |
| Z-0971-2020 | Urethral Dilator Set, Global Product No. G14185 | 13388 total | Class II | Terminated | 12 Feb 2020 |
| Z-0972-2020 | Bander Ureteral Diversion Open-End Stent Set, Global Product No. G14822 G14823 | 13388 total | Class II | Terminated | 12 Feb 2020 |
| Z-0973-2020 | C-Flex Double Pigtail Ureteral Stent Set, Global Product No. G14364 G14365 G14367 | 13388 total | Class II | Terminated | 12 Feb 2020 |
| Z-0974-2020 | Kwart Retro-Inject Ureteral Stent Set, Global Product No. G15016 G14836 G14885 G14887 G17151 | 13388 total | Class II | Terminated | 12 Feb 2020 |
| Z-0975-2020 | Sof-Flex Double Pigtail Ureteral Stent Set, Global Product No. G15076 G14906 G14840 G14865 G17128 | 13388 total | Class II | Terminated | 12 Feb 2020 |
| Z-0976-2020 | Sof-Flex Multi-Lenqth Ureteral Stent Set, Global Product No. G14773 G15000 G14867 G14951 G17852 | 13388 total | Class II | Terminated | 12 Feb 2020 |
| Z-0977-2020 | Universa Firm Ureteral Stent, Global Product No. G49864 G49865 G49866 G49867 G49868 G49869 G49870 G49874 G49875 G49877 G49879 G49881 G49882 G49887 G49888 | 13388 total | Class II | Terminated | 12 Feb 2020 |
| Z-0978-2020 | Universa Soft Ureteral Stent, Global Product No. G49887 G49933 G49934 G49937 G49940 G49941 G49942 G49945 G49947 G49948 G49949 G49950 G49951 G49953 G49955 G49956 G49957 G49958 G49959 G49961 G53145 G53676 G53677 G53687 G53689 G53692 G53693 G53694 G53703 G53706 G53711 G53723 G53724 G53725 G53726 | 13388 total | Class II | Terminated | 12 Feb 2020 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2019
- 968
- Share of these events in Class II
- 88%
- Product records in this event
- 20Median of the firm: 2
- Events of the firm on the register
- 61
Other events of the firm
Official channels
- FDA enforcement report Z-0959-2020The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 82026. https://recallregister.com/fda/ii/82026/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Domestic distribution to nationwide US. Foreign distribution to Australia, Belgium, Bolivia, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, France, French…
- What quantity of product is in FDA event 82026?
- The event has 20 product records. The first record gives this quantity:
1079
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2019 have the same class?
- 88% of the 968 device events that started in 2019 are in Class II.