Roadrunner recallZ-1837-2022 · Cook Incorporated · initiated Aug 16, 2022

Why it was recalled

Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.

FDA root cause category: Under Investigation by firm

What the company is doing

On August 16, 2022, Cook Medical notified affected customers of the recall. Customers were instructed to immediately cease all further distribution and use of the affected products. Affected product should be quarantined and returned to Cook Medical to receive product credit. If you have any questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235

Recall details

Recall number

Z-1837-2022

Status

Open, Classified

Initiated by the company

Aug 16, 2022

Posted by the FDA

Sep 28, 2022

Recalling firm

Cook Incorporated

Quantity

56 US; 1033 OUS

Product code

OCY

FDA submissions

K082536

Distribution

Domestic distribution nationwide. Foreign distribution worldwide.

Product description

Roadrunner PC Hydrophilic Wire Guide, Hydrophilic Guidewire Reference Part Number/GPN: RPC-035145-0-5 G34131 RPC-035145 G18154 RPC-035145-5 G34132 RPC-038145-0-5 G34129 RFSPC-038145-0 G17539 RFSPC-035145 G17540 RPC-038145-0 G18155 RPC-035145-0 G18153 RFSPC-035145-0 G17542

Devices named in this recall

6 devices in the FDA device registry whose identifier appears in the recall's code information.

• Roadrunner G18154

  Cook Incorporated · Endoscopic guidewire, gastroenterology-urology
  1 recall18 reports
• Roadrunner G17542

  Cook Incorporated · Endoscopic guidewire, gastroenterology-urology
  1 recall9 reports
• Roadrunner G18153

  Cook Incorporated · Endoscopic guidewire, gastroenterology-urology
  1 recall6 reports
• Roadrunner G18155

  Cook Incorporated · Endoscopic guidewire, gastroenterology-urology
  1 recall3 reports
• Roadrunner G17539

  Cook Incorporated · Endoscopic guidewire, gastroenterology-urology
  1 recall2 reports
• Roadrunner G17540

  Cook Incorporated · Endoscopic guidewire, gastroenterology-urology
  1 recall0 reports

Product lines

• RoadrunnerCook Incorporated · 28 models · 183 reports · 9 recalls

Other products in the same recall event

The FDA groups related products into one recall event (event 90793).

• Z-1824-2022 · Open, Classified
  Amplatz extra Stiff Wire Guide, Stiff Guidewire (OUS ONLY); Reference Part Number: THSF-35-145-AES-SGH (GPN G06801) THSF-38-80-AES-SGH (GPN G06874)
• Z-1825-2022 · Open, Classified
  Bentson Plus Wire Guide (Extra Body/20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part Number: TSFBP-35-180 (GPN G09782) TSFBP-35-145 (GPN G09735)
• Z-1826-2022 · Open, Classified
  Bentson Wire Guide, Guidewire (OUS ONLY); Reference Part Number: TSMB-35-145 (GPN G27041)
• Z-1827-2022 · Open, Classified
  Bentson Wire Guide (20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part Number: TSFB-35-80 (GPN G01315) TSFB-35-145 (GPN G00691) TSFB-35-200 (GPN G01095)
• Z-1828-2022 · Open, Classified
  Coons Interventional Wire Guide, Guidewire; Reference Part Number/GPN: THSF-35-145-COONS G02356 THSF-38-145-COONS G02324 THSF-35-180-COONS G02621 THSF-35-80-COONS G12268
• Z-1829-2022 · Open, Classified
  Cope Mandril Wire Guide (Nitinol), Nitinol Guidewire; Reference Part Number/GPN: PMG-18SP-60-COPE-NT-ST G09395 PMG-18SP-100-COPE-NT G08687 PMG-18SP-60-COPE-NT G08427
• Z-1830-2022 · Open, Classified
  Cope Mandril Wire Guide (Stainless Steel), Stainless Steel Guidewire Reference Part Number/GPN PMG-18SP-60-COPE G05183 PMG-18SP-100-COPE G05822 PMG-18SP-125-COPE G10077
• Z-1831-2022 · Open, Classified
  Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN TDOC-35-145-0-3 G00362 C-TDOC-18-50-0-2 G05146 TDOC-35-50-0-3 G00364 C-DOC-21-40-0-2 G02431 C-TDOC-21-50-0-2 …
• Z-1832-2022 · Open, Classified
  Fixed Core Wire Guide, Guidewire Reference Part Number/GPN THSCF-25-180-3 G02165 TSCF-25-80-3 G00476
• Z-1833-2022 · Open, Classified
  Fixed Core Wire Guide (Safe-T-J Curved), Guidewire Reference Part Number/GPN: TSCF-25-180-3 G01602 TSCF-35-180-3 G00902 TSCF-21-260-3 G00455 THSCF-25-260-3 G02384 TSCF-25-145-3 G00…
• Z-1834-2022 · Open, Classified
  Fixed Core Wire Guide (Straight), Guidewire Reference Part Number/GPN: C-SF-18-30 G02261 C-SF-25-40 G01937 TSF-18-260 G00590 C-SF-25-50 G01938 TSF-35-180 G00652 C-SF-18-40 G02255 T…
• Z-1835-2022 · Open, Classified
  Heavy Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN: THDOC-35-60-0-3 G11949 C-HDOC-18-40-0-2 G09201 C-THDOC-18-40-0-2-HTS G26925
• Z-1836-2022 · Open, Classified
  Newton Wire Guide (LT Taper/10cm Distal Flexibility), Guidewire Reference Part Number/GPN: TSFNA-35-145 G00701 TSCFNA-35-145-3 G00561
• Z-1838-2022 · Open, Classified
  Roadrunner PC Wire Guide (Nimble), Guidewire Reference Part Number/GPN: RFSPC-35-145 G09607
• Z-1839-2022 · Open, Classified
  Roadrunner PC Wire Guide (Nimble Floppy), Guidewire RFPC-35-145 G07914
• Z-1840-2022 · Open, Classified
  Roadrunner PC Wire Guide (The Firm LT), Guidewire Reference Part Number/GPN RLPC-35-145 G06866
• Z-1841-2022 · Open, Classified
  Roadrunner PC Wire Guide (The Firm), Guidewire Reference Part Number/GPN RPC-35-145 G06979 RPC-35-80 G09534
• Z-1842-2022 · Open, Classified
  Rosen Curved Wire Guide, Guidewire Reference Part Number/GPN THSCF-35-220-1.5-ROSEN G01623 THSCF-35-80-1.5-ROSEN G01774 THSCF-35-180-1.5-ROSEN G01264 THSCF-35-145-1.5-ROSEN G01261
• Z-1843-2022 · Open, Classified
  Torq-Flex Wire Guide Australian Modification, Guidewire Reference Part Number/GPN STF-18-40-AUST G07304
• Z-1844-2022 · Open, Classified
  Vinyl Connecting Tube, Connecting Tube Reference Part Number/GPN CTU14.0-30-ST G02278 CTU14.0-40-ST G02327 CTU14.0-30 G02791 CTU14.0-50-ST G02464 C-CTU14.0-30-ST G02898
• Z-1845-2022 · Open, Classified
  Lunderquist -Ring Torque Wire Guide, Guidewire Reference Part Number/GPN THSF-35-125-THG G27031 THSF-35-145-THG G27033
• Z-1846-2022 · Open, Classified
  Movable Core Wire Guide (Tapered Tefcor) (OUS ONLY), Guidewire Reference Part Number/GPN TCMTNA-35-145-3 G01678
• Z-1847-2022 · Open, Classified
  Movable Core Wire Guide (Tefcor), Guidewire (OUS ONLY) Reference Part Number/GPN TMT-35-145 G01677