Recall Z-0731-2016— Baxter Corporation Englewood

Name: FDA recall Z-0731-2016
Creator: U.S. Food and Drug Administration
Published: 2015-12-21

Class II · Terminated

Class II FDA medical device recall by Baxter Corporation Englewood, initiated 2015-12-21, terminated 2016-08-18. It names one FDA 510(k) clearance: K980181. Product: Baxter, RAPIDFILL Syringe Strip, 10 ml. For use with RAPIDFILL Automated Syringe Filler (ASF). Reason: All lots of RAPIDFILL Syringe Strips lack evidence supporting the packaging claim for 12-month shelf life on released product..

Recalling firm: Baxter Corporation Englewood
Classification: Class II
Status: Terminated
Initiated: 2015-12-21
Terminated: 2016-08-18
Firm location: Englewood, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K980181 — TERUMO DISPOSABLE HYPODERMC SYRINGETerumo Medical Corp.·cleared 1998-04-02

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

Baxter, RAPIDFILL Syringe Strip, 10 ml. For use with RAPIDFILL Automated Syringe Filler (ASF)

Reason for recall

All lots of RAPIDFILL Syringe Strips lack evidence supporting the packaging claim for 12-month shelf life on released product.

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