—#126847

Product

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

FDA product code: BSP — Needle, Conduction, Anesthetic (W/Wo Introducer)
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K932569
Affected lot / code info: 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%

Why it was recalled

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

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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 PA_QualityAssurance.BBMUS_Service@bbraun.com 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.

Recalling firm

Firm: B. Braun Medical, Inc.
Address: 901 Marcon Blvd, Allentown, Pennsylvania 18109-9512

Distribution

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

Timeline

Recall initiated: 2014-04-03
Posted by FDA: 2014-05-28
Terminated: 2014-12-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #126847. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.