Recall Z-2670-2014— Centurion Medical Products Corporation

Name: FDA recall Z-2670-2014
Creator: U.S. Food and Drug Administration
Published: 2014-07-25

Class II · Terminated

Class II FDA medical device recall by Centurion Medical Products Corporation, initiated 2014-07-25, terminated 2014-11-25. It names one FDA 510(k) clearance: K042061. Product: 0.9% Sodium Chloride Injection, USP BD PosiFlush(TM) SF Saline Flush Syringe 10 mL REF#306553 used in Centurion Convenience Kits. Recalled product is attached to the outside of the Convenience Kits.. Reason: Unit packages may exhibit open seals which impacts package integrity and potentially product sterility..

Recalling firm: Centurion Medical Products Corporation
Classification: Class II
Status: Terminated
Initiated: 2014-07-25
Terminated: 2014-11-25
Firm location: Williamston, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K042061 — 0.9% SODIUM CHLORIDE INJECTION, USP BD POSTFLUSH SF FLUSH SYRINGEBecton Dickinson·cleared 2004-08-26

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

0.9% Sodium Chloride Injection, USP BD PosiFlush(TM) SF Saline Flush Syringe 10 mL REF#306553 used in Centurion Convenience Kits. Recalled product is attached to the outside of the Convenience Kits.

Reason for recall

Unit packages may exhibit open seals which impacts package integrity and potentially product sterility.

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