Recall Z-1404-2015— Teleflex Medical

Name: FDA recall Z-1404-2015
Creator: U.S. Food and Drug Administration
Published: 2015-03-13

Class II · Terminated

Class II FDA medical device recall by Teleflex Medical, initiated 2015-03-13, terminated 2017-08-14. It names one FDA 510(k) clearance: K962856. Product: Pluer-evac Sahara Chest Drainage System, S-1100-08LF, Dry Suction/Dry Seal Control, Rx Only, Teleflex Medical.. Reason: Package contains incorrect sized unit: The adult sized S-1100-08LF product contains an infant sized chest drainage system..

Recalling firm: Teleflex Medical
Classification: Class II
Status: Terminated
Initiated: 2015-03-13
Terminated: 2017-08-14
Firm location: Research Triangle Park, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K962856 — PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTRDeknatel, Inc.·cleared 1996-08-28

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

Pluer-evac Sahara Chest Drainage System, S-1100-08LF, Dry Suction/Dry Seal Control, Rx Only, Teleflex Medical.

Reason for recall

Package contains incorrect sized unit: The adult sized S-1100-08LF product contains an infant sized chest drainage system.

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