Recall Z-0978-2020
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
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
Codes / lots: 8078013 8172113 8001369 8183381 NS7994828 8147249 8417607 8600625 NS8417608 NS7990886 7990888 8594598 8594599 8056338 8018675 8056337 8629502 NS8018677 NS8053511 NS8417612 NS8011064 NS8417614 NS8417615 7998415 8147267 8187145 8008415 8011065 8078026 8008416 8078027 8078028 8150465 8180873 8008417 8033600 8427840 8427841 8507952 8507953 8507954 8507955 7990900 8003104 NS7990899 7998422 7998423 8047039 8056331 8066970 8066972 8066973 8066974 8147295 8147296 8421552 8427843 8427847 8594610 7994831 8008426 8056327 8066976 8066977 8207795 8629522 NS8026827 NS8030272 NS8421563 NS8421564 NS8421566 NS8421567 8599661 8421568 NS8599665 NS8060481 NS8033606 NS8629506 NS8629507 NS8008428 NS8421571 NS8421572 NS8599666 NS8599667 NS8147321 NS8421573 NS8008429
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-0978-2020
- Initiated
- January 4, 2019
- Terminated
- May 29, 2020
- Product code
- FAD – Stent, Ureteral
- 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-0965-2020 Class II | Angled Tip Ureteral Catheter Set, Ureteral Catheter, Global Product No. G14598The 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 |