Mahurkar Oplus Catheter, Model 13.5 Fr

• • Ongoing Z-0877-2023 FDA Class I ·initiated 7 Dec 2022 ·on shared 510(k) K030209

  There is a potential leaking condition within the hub of affected devices, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.

• • Terminated Z-1955-2019 FDA Class II ·initiated 29 Apr 2019 ·on shared 510(k) K030209

  The priming volume values printed on the MAHURKA and Argyle acute catheters and Instructions for Use (IFU) are higher than the volumes required to fill each lumen.

• • Terminated Z-0233-04 FDA Unclassified (pre-2012) ·initiated 2 Dec 2003

  Product is mislabeled to catheter length. Product labeled as a 13.5 Fr x 19.5 cm may contain a 13.5Fr x 16.0 cm

• • Terminated Z-0234-04 FDA Unclassified (pre-2012) ·initiated 2 Dec 2003

  Product is mislabeled to catheter length. Product labeled as a 13.5 Fr x 19.5 cm may contain a 13.5 Fr x 16.0 cm

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

510(k) Number

K030209 ↗

FDA Product Code

MPB

Device Class

Class II

Regulation

21 CFR Part 876.5540

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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