Portex Spinal Tray with Drugs 25g Whitacre; 15597-20 The Regional Anesthesia family of products is comprised of sterile

FDA device recall Z-0160-2014 · posted 2013-11-05 · Terminated

Recall details

Recalling firm

Smiths Medical ASD, Inc.

Reason for recall

Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Ampoule, NDC # 0409-4712-01, Hospira Lot Number 23-227-DK. These ampules are included in certain Portex Spinal Anaesthesia Trays.

Action taken

Smiths Medical sent an Urgent Recall Notice dated September 23, 2013, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inspect their inventory for the affected product and remove from use. Complete the Confirmation Form and return by fax to 603-358-1017 or by email to spinal@smiths-medical.com. Upon receipt of the completed form, a customer service representative would contact them to arrange for exchange of their unused affected devices for credit or replacement. Customers were also instructed to forward the notice to all personnel who need to be aware within their organization. Customers with questions were instructed to contact Smiths Medical's Customer Service Department at 800-258-5361. For questions regarding this recall call 800-258-5361.

Root cause

Material/Component Contamination

Status

Terminated

Product code

CAZ

Quantity affected

3980

Distribution

Nationwide Distribution including AK, AR, AZ, CA, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, RI, SC, TX, UT, VA, VT, WA, WI, WY.

Date initiated

2013-09-23

Date posted

2013-11-05

Date terminated

2016-08-22

Location

Keene, NH