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Recall Observatory FDA recall evidence

Device product

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

Z-1666-2014

April 03, 2014

Class II

Product summary

Firm
B. Braun Medical, Inc.
Event
Event 68040
Status
Terminated
Classification
Class II
Quantity
7400
Official record key
device-enforcement:Z-1666-2014

Official wording

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

Code information: catalog no. 333740, lot no. 61358613, exp. 4/30/2015: Sprotte Spinal Tray, 24 gauge with 2mL Bupivacaine .75% with Dextrose 8.25% catalog no. 333741, lot no 61352071,exp. 12/31/2018: Sprotte Pencil Point Spinal Needle 24 gauge with Introducer catalog no. 333742, lot no.61350129, exp. 5/31/2015: Sprotte Spinal Tray, 24 gauge with 2mL Lidocaine 5% with Dextrose 7.5% catalog no. 560581, lot no.61354298, exp. 4/30/2015: Sprotte Spinal Tray 24 gauge with 2mL Bupivacaine .75% with Dextrose 8.25%

Distribution pattern: Worldwide Distribution - USA (nationwide) and to Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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