Recall Z-1666-2014— B. Braun Medical, Inc.

Name: FDA recall Z-1666-2014
Creator: U.S. Food and Drug Administration
Published: 2014-04-03

Class II · Terminated

Class II FDA medical device recall by B. Braun Medical, Inc., initiated 2014-04-03, terminated 2014-12-02. It names one FDA 510(k) clearance: K932569. Product: Sprotte Spinal Tray / Sprotte Spinal Needle 24 gauge with Introducer Spinal injection of anesthetics to provide regional anesthesia. Reason: B.Braun Medical, Inc. (BBMI) has received reports of 24 gauge Sprotte Needles that are missing the accompanying introducer needles..

Recalling firm: B. Braun Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-04-03
Terminated: 2014-12-02
Firm location: Allentown, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K932569 — PENCIL POINT SPINAL NEEDLE AND TRAYB. Braun of America, Inc.·cleared 1994-01-26

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

Sprotte Spinal Tray / Sprotte Spinal Needle 24 gauge with Introducer Spinal injection of anesthetics to provide regional anesthesia

Reason for recall

B.Braun Medical, Inc. (BBMI) has received reports of 24 gauge Sprotte Needles that are missing the accompanying introducer needles.

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