Recall Z-1582-2016— Teleflex Medical

Name: FDA recall Z-1582-2016
Creator: U.S. Food and Drug Administration
Published: 2016-03-30

Class II · Terminated

Class II FDA medical device recall by Teleflex Medical, initiated 2016-03-30, terminated 2025-01-30. It names one FDA 510(k) clearance: K140205. Product: Pleur-evac Chest Drainage System, Dry Suction/Dry Seal Control, REF A-6000-08LF, Rx Only, Teleflex Medical. Product Usage: Pleur-Evacs are sterile, single-use, chest drainage systems intended for post-operative use. Reason: The label on the Tyvek bag is missing. This is used by customers to identify material code, lot number, and expiration date once the product is removed from the shipper box..

Recalling firm: Teleflex Medical
Classification: Class II
Status: Terminated
Initiated: 2016-03-30
Terminated: 2025-01-30
Firm location: Research Triangle Park, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K140205 — PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEMTeleflexmedical, Inc.·cleared 2014-10-23

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

Pleur-evac Chest Drainage System, Dry Suction/Dry Seal Control, REF A-6000-08LF, Rx Only, Teleflex Medical. Product Usage: Pleur-Evacs are sterile, single-use, chest drainage systems intended for post-operative use

Reason for recall

The label on the Tyvek bag is missing. This is used by customers to identify material code, lot number, and expiration date once the product is removed from the shipper box.

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