Retiro De Equipo (Recall) de Sprotte Spinal Tray / Sprotte Spinal Needle 24 gauge with Introducer

Recall

68040

Class 2

Z-1666-2014

2014-04-03

2014-05-28

Terminated

United States

2014-12-02

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126847

B.Braun medical, inc. (bbmi) has received reports of 24 gauge sprotte needles that are missing the accompanying introducer needles.

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.