N/A QPC1713

• • Terminated Z-1180-2016 FDA Class II ·initiated 4 Dec 2015

  The firm discovered that one of the hysteroscope models listed for processing in four existing Quick Connects has one inlet port rather than two inlet ports as indicated in the Quick Connect processing instructions.

• • Terminated Z-0616-2014 FDA Class II ·initiated 21 Nov 2013 ·via K131078, on the same 510(k)

  Customers indicated fluctuations in environmental conditions sites and gradual degradation/deformation of check valve o-rings following frequent contact with S40 sterilant use solution result in nuisance aborts.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Trade Name

N/A

Generic Name

Luminal device flushing tubing set, reusable

Model / Reference

QPC1713

Primary DI / UDI-DI

04961333244270

510(k) Number

K131078 ↗

FDA Product Code

MED

GMDN Term

Luminal device flushing tubing set, reusable

Device Class

Class II

Regulation Number

880.6885

Commercial Distribution

In Commercial Distribution

Sterilization Method

High-level Disinfectant

Category: Luminal device flushing tubing set, reusable

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