Z-1666-2014Class II

Sprotte Spinal Tray / Sprotte Spinal Needle 24 gauge with Introducer Spinal injection of anesthetics to...

Name: Z-1666-2014 Sprotte Spinal Tray / Sprotte Spinal Needle 24 gauge with Introducer Spinal injection of anesthetics to...
Creator: B. Braun Medical, Inc.
Published: 2014-04-03
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2014-04-03 / Terminated / root cause: manufacturing process

FDA source

B. Braun Medical, Inc. began a recall of Sprotte Spinal Tray / Sprotte Spinal Needle 24 gauge with Introducer Spinal injection of anesthetics to provide regional anesthesia on 2014-04-03. FDA classified it as Class II and gives the reason as "B.Braun Medical, Inc. (BBMI) has received reports of 24 gauge Sprotte Needles that are missing the accompanying introducer needles". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1666-2014
Classification: Class II
Status: Terminated
Initiated: 2014-04-03
Posted: 2014-05-28
Terminated: 2014-12-02
Recalling firm: B Braun Medical Inc
Product: Sprotte Spinal Tray / Sprotte Spinal Needle 24 gauge with Introducer Spinal injection of anesthetics to provide regional anesthesia
Product code: BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
Reason for recall: B.Braun Medical, Inc. (BBMI) has received reports of 24 gauge Sprotte Needles that are missing the accompanying introducer needles.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: B/Braun sent an Urgent Medical Device Recall Notification letter dated April 3, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the Device Recall Notification in its entirety and ensure that all users in their organization and other concerned persons are informed about this voluntary product recall. The letter should also be forwarded to their customers. Customers were instructed to determine their current inventory of the affected lots within their facility, DO NOT DESTROY ANY AFFECTED PRODUCT. Further use of the affected product should be discontinued immediately and quarantined. Customers should use the attached Product Removal Acknowledgement form to record the total number of inidividual units. If cusotmers have no remaining inventory they should check the box indicating zero inventory. Return the completed Product Removal Acknowledgement form to BBMI Quality Assurance department by fax to 610-849-1197 or email to [email protected] within 2 weeks of receipt, even if the inventory is zero (0). If customers have any affected product they should call BBMI Customer Support Department at 800-227-2862 to arrange for return and replacement product. Customers with questions were instructed to call the Clinical and Technical Support Department at 1-800-854-6851. For questions regarding this recall call 610-596-2870.
Quantity in commerce: 7400
Distribution: Worldwide Distribution - USA (nationwide) and to Canada.
Product codes and lots: 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%

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1666-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1666-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-04	2014-05-28

Product code BSP

K932569Class IIPencil Point Spinal Needle and TrayB. Braun of America, Inc. / cleared 1994-01-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)