Recall Z-0965-2020
Cook Inc. · initiated January 4, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Angled Tip Ureteral Catheter Set, Ureteral Catheter, Global Product No. G14598
Codes / lots: 8023195 8314384 8409525 NS8040177 7857489
Reason for recall
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.
FDA-determined cause: Process control
Action taken
On January 4, 2019, the firm distributed Urgent Medical Device Recall letters to customers via courier mail. Customers were informed that affected lots may contain a wire guide that was incorrectly loaded into the wire guide holder.
Details
- Recall number
- Z-0965-2020
- Initiated
- January 4, 2019
- Terminated
- May 29, 2020
- Product code
- OCY – Endoscopic Guidewire, Gastroenterology-Urology
- Quantity
- 13388 total
- Distribution
- Domestic distribution to nationwide US. Foreign distribution to Australia, Belgium, Bolivia, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, France, French Polynesia, Germany, Guatemala, Honduras, Hungary, India, Ireland, Italy, Japan, Korea, Luxembourg, Malaysia, Malta, Mexico, Mongolia, Netherlands, New Caledonia, New Zealand, Oman, Panama, Paraguay, Poland…
- Recalling firm
- Cook Inc., Bloomington, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0959-2020 Class II | Bentson PTFE Wire Guide, Guidewire, Global Product Number G14589, G14590The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire… | 01/04/2019Terminated |
| Z-0960-2020 Class II | Fixed Core Straight Safety Wire Guide, Guidewire, Global Product Number G14285The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire… | 01/04/2019Terminated |
| Z-0961-2020 Class II | Heavy Duty PTFE Wire Guide, Guidewire, Global Product Number G14323 G14260 G14260The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire… | 01/04/2019Terminated |
| Z-0962-2020 Class II | PTFE Wire Guide, Guidewire, Global Product Number 638813 635413-10The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire… | 01/04/2019Terminated |
| Z-0963-2020 Class II | Roadrunner Hydrophilic PC Wire Guide, Guidewire, Global Product Number G18629, G17866The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire… | 01/04/2019Terminated |
| Z-0964-2020 Class II | Wire Guide, Guidewire, Global Product Number G14326The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire… | 01/04/2019Terminated |
| Z-0966-2020 Class II | Angled Tip Ureteral Catheter Set with Bentson PTFE Wire Guide, Ureteral Catheter, Global…The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire… | 01/04/2019Terminated |
| Z-0967-2020 Class II | Percutaneous Entry Set, Nephrostomy Catheter, Global Product No. G14649The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire… | 01/04/2019Terminated |
| Z-0968-2020 Class II | Percutaneous Malecot Nephrostomy Set, Global Product No. G16714 G19107 G19108The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire… | 01/04/2019Terminated |
| Z-0969-2020 Class II | Percutaneous Pigtail Nephrostomy Set , Global Product No. G14094 G14095 G14899 G14329The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire… | 01/04/2019Terminated |
| Z-0970-2020 Class II | Urethral Dilation Balloon Catheter with Open Tip , Global Product No. G17844The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire… | 01/04/2019Terminated |
| Z-0971-2020 Class II | Urethral Dilator Set, Global Product No. G14185The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire… | 01/04/2019Terminated |
| Z-0972-2020 Class II | Bander Ureteral Diversion Open-End Stent Set, Global Product No. G14822 G14823The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire… | 01/04/2019Terminated |
| Z-0973-2020 Class II | C-Flex Double Pigtail Ureteral Stent Set, Global Product No. G14364 G14365 G14367The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire… | 01/04/2019Terminated |
| Z-0974-2020 Class II | Kwart Retro-Inject Ureteral Stent Set, Global Product No. G15016 G14836 G14885 G14887…The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire… | 01/04/2019Terminated |
| Z-0975-2020 Class II | Sof-Flex Double Pigtail Ureteral Stent Set, Global Product No. G15076 G14906 G14840…The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire… | 01/04/2019Terminated |
| Z-0976-2020 Class II | Sof-Flex Multi-Lenqth Ureteral Stent Set, Global Product No. G14773 G15000 G14867 G14951…The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire… | 01/04/2019Terminated |
| Z-0977-2020 Class II | Universa Firm Ureteral Stent, Global Product No. G49864 G49865 G49866 G49867 G49868…The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire… | 01/04/2019Terminated |
| Z-0978-2020 Class II | Universa Soft Ureteral Stent, Global Product No. G49887 G49933 G49934 G49937 G49940…The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire… | 01/04/2019Terminated |