Recall Z-1149-2017— Stryker Leibinger GmbH & Co. KG

Name: FDA recall Z-1149-2017
Creator: U.S. Food and Drug Administration
Published: 2017-01-03

Class II · Terminated

Class II FDA medical device recall by Stryker Leibinger GmbH & Co. KG, initiated 2017-01-03, terminated 2017-07-27. It names one FDA 510(k) clearance: K833586. Product: QUINTUBE Monitor Pack (5 tubes/pk, 24 pk/case) (Non-Sterile) SPG Bulb Drain System, 4mm Flat w/Center Holes (Sterile) Accessories to TLS Surgical Drainage System. Reason: An incorrect sterility status on the label, non-sterile products labeled as sterile.

Recalling firm: Stryker Leibinger GmbH & Co. KG
Classification: Class II
Status: Terminated
Initiated: 2017-01-03
Terminated: 2017-07-27
Firm location: Freiburg, N/A, Germany

510(k) clearances named in this recall

1 on FDA's record

K833586 — TLS BULB DRAINAGE SYSTEMPorex Medical·cleared 1984-01-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

QUINTUBE Monitor Pack (5 tubes/pk, 24 pk/case) (Non-Sterile) SPG Bulb Drain System, 4mm Flat w/Center Holes (Sterile) Accessories to TLS Surgical Drainage System

Reason for recall

An incorrect sterility status on the label, non-sterile products labeled as sterile

Data sourced from openFDA. This site is unofficial and independent of the FDA.