FDAFDA · Food and drugs·Recall number Z-1666-2014
Sprotte Spinal Tray / Sprotte Spinal Needle 24 gauge with Introducer Spinal injection of anesthetics to provide regional anesthesia
Published June 4, 2014 · Recall initiated: April 3, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
B.Braun Medical, Inc. (BBMI) has received reports of 24 gauge Sprotte Needles that are missing the accompanying introducer needles.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- B. Braun Medical, Inc.
- Distributor
- Worldwide Distribution - USA (nationwide) and to Canada.
- Lot
- 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%
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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