Tandem-Cath 10 Fr. Catheter System, Model Multiple Code Numbers

• 5 recalls, same reason

  • Terminated Z-0742-03 FDA Unclassified (pre-2012) ·initiated 20 Mar 2003 ·on shared 510(k) K002902
  • Terminated Z-0746-03 FDA Unclassified (pre-2012) ·initiated 20 Mar 2003 ·on shared 510(k) K002902
  • Terminated Z-0743-03 FDA Unclassified (pre-2012) ·initiated 20 Mar 2003 ·on shared 510(k) K002902
  • Terminated Z-0747-03 FDA Unclassified (pre-2012) ·initiated 20 Mar 2003 ·on shared 510(k) K002902
  • Terminated Z-0744-03 FDA Unclassified (pre-2012) ·initiated 20 Mar 2003 ·on shared 510(k) K002902

  Tandem Hemodialysis Catheter may have splits in the catheter shaft below the extension adapter

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K002902 ↗

FDA Product Code

MSD

Device Class

Class II

Regulation

21 CFR Part 876.5540

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Mahurkar Oplus Catheter, Model 13.5 Fr Open recall

  Class II

  FDA 510(k) K030209 Active Cleared 13 May 2003

• Kendall Model 7325 Scd Response Compression System, Model 7325

  Class II

  FDA 510(k) K992079 Active Cleared 29 Sep 1999

• Kerlix Md Antimicrobial Gauze Dressing

  Class I

  FDA 510(k) K990530 Active Cleared 31 Jan 2000

• Kendall Argyle Neonatal/Pediatric Picc, Model 43311

  Class II

  FDA 510(k) K061936 Active Cleared 9 Aug 2006

• Filac Fas Temp Electronic Thermometer

  Class II

  FDA 510(k) K003313 Active Cleared 11 Jan 2001

• Excilon Amd Antimicrobial Sponge Model #7088

  Unclassified

  FDA 510(k) K011941 Active Cleared 22 Aug 2001

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