Recall Z-1183-2014— Smiths Medical ASD, Inc.

Name: FDA recall Z-1183-2014
Creator: U.S. Food and Drug Administration
Published: 2013-11-22

Class II · Terminated

Class II FDA medical device recall by Smiths Medical ASD, Inc., initiated 2013-11-22, terminated 2020-11-20. It names one FDA 510(k) clearance: K952516. Product: 4043G-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device and ice bag Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.. Reason: issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes.

Recalling firm: Smiths Medical ASD, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-11-22
Terminated: 2020-11-20
Firm location: Keene, NH, United States

510(k) clearances named in this recall

1 on FDA's record

K952516 — PRO-VENT, LINE DRAW, PULSATORSmiths Industries Medical Systems, Inc.·cleared 1995-07-14

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

4043G-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device and ice bag Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.

Reason for recall

issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes

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