Medium RiskFDA Device

Cook Inc.: 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.

Agency Publication Date: February 4, 2020

Affected Products

Product: Bentson PTFE Wire Guide, Guidewire, Global Product Number G14589, G14590

7832513 7832514 8062406 8062407 8065988 8065989 8065992 8404354 8404355 8547811 8069648

Product: Fixed Core Straight Safety Wire Guide, Guidewire, Global Product Number G14285

7971639

Product: Heavy Duty PTFE Wire Guide, Guidewire, Global Product Number G14323 G14260 G14260

7875295 8481133 NS8481135

Product: PTFE Wire Guide, Guidewire, Global Product Number 638813 635413-10

7832498 7832499 7832500 7925385 7925387 7930517 8090868 8287793 8287794 8287799 8400121 8548813 8548815 NS8548814 7760235 7881599 8062433 8074027 8290383 8290384 8404559 8404562 7999663 8077582 8077583 8065959 8073949 8074014 8074015

Product: Roadrunner Hydrophilic PC Wire Guide, Guidewire, Global Product Number G18629, G17866

7853231 7853232 7853233 7853239 7853240 7853241 7853242 7853243 7853245 7853247 7901140 7901141 7982113 7982118 7982133 8050291 8241613 8241616 8252179 8252181 8252186 8258553 8283322 8407934 8460985 8474895 8474898 8474905 8474906 8474908 8474909 8474910 7936207

Product: Wire Guide, Guidewire, Global Product Number G14326

7857489

Product: Angled Tip Ureteral Catheter Set, Ureteral Catheter, Global Product No. G14598

8023195 8314384 8409525 NS8040177 7857489

Product: Angled Tip Ureteral Catheter Set with Bentson PTFE Wire Guide, Ureteral Catheter, Global Product No. G19108 G14587 G15302 G14326

8018728 8080823 8314382 8409523 8023194 7857489

Product: Percutaneous Entry Set, Nephrostomy Catheter, Global Product No. G14649

8109245 NS8109246

Product: Percutaneous Malecot Nephrostomy Set, Global Product No. G16714 G19107 G19108

NS8070854 8078209 8116743

Product: Percutaneous Pigtail Nephrostomy Set , Global Product No. G14094 G14095 G14899 G14329

8112670 8113259 8113260 8113261 NS8070847 8076035

Product: Urethral Dilation Balloon Catheter with Open Tip , Global Product No. G17844

8494465 8513227 8537103 8537104 8552050 8552051 8567256 8576963 8632766 8639366 8659206 8683459 8754089 NS8513228

Product: Urethral Dilator Set, Global Product No. G14185

8401849 8404945 8404946 8417702 8404946X

Product: Bander Ureteral Diversion Open-End Stent Set, Global Product No. G14822 G14823

8011030 8033568 8063430 8063431 8150491 8417631 8417632 8587162 8587163 8590532 8590533 7990830 8003084 8033571 8063428 8590520 8590522 8629475 NS8629473

Product: C-Flex Double Pigtail Ureteral Stent Set, Global Product No. G14364 G14365 G14367

NS7953136 NS8169661 NS8180857 NS8169662 NS8180858 NS8180859 NS8180860

Product: Kwart Retro-Inject Ureteral Stent Set, Global Product No. G15016 G14836 G14885 G14887 G17151

8011027 8183322 8037660 8030233 8018054 7994816

Product: Sof-Flex Double Pigtail Ureteral Stent Set, Global Product No. G15076 G14906 G14840 G14865 G17128

NS7949093 NS8077953 NS8077954 NS8077955 8070691 8183342 8183343 8070693 8172134 8187189 NS8070692 8424304 7990841

Product: Sof-Flex Multi-Lenqth Ureteral Stent Set, Global Product No. G14773 G15000 G14867 G14951 G17852

8011038 NS7998389 NS8008388 NS8018651 NS8030247 NS8037667 7990842 8599605 8625597 8625598 8172131 8172132 8193001

Product: Universa Firm Ureteral Stent, Global Product No. G49864 G49865 G49866 G49867 G49868 G49869 G49870 G49874 G49875 G49877 G49879 G49881 G49882 G49887 G49888

7953153 8077981 8070702 NS8176831 7999744 7999746 8077986 8077988 8172070 8176832 8176833 8176834 NS7999747 NS8180869 7990863 8424316 8424317 8424318 NS7990867 7988039 7998403 7998404 8001365 8040131 8193749 8197930 8197931 8412989 8412990 8424332 7988039X 8003098 8506037 NS8018667 8594594 8197932 8594595 NS8197934 NS8417599 NS8417600 NS7998407 NS8033592 NS8033593

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

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

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82026

Status: Resolved

Manufacturer: Cook Inc.

Manufactured In: United States

Units Affected: 20 products (1079; 15; 146; 3929; 13388 total; 13388 total; 13388 total; 13388 total; 13388 total; 13388 total; 13388 total; 13388 total; 13388 total; 13388 total; 13388 total; 13388 total; 13388 total; 13388 total; 13388 total; 13388 total)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.