Lubricated Intubating Stylet 6FR that is inserted into an endotracheal tube to facilitate intubation. This product is us

FDA device recall Z-1054-2015 · posted 2015-02-04 · Terminated

Recall details

Recalling firm

Cardinal Health

Reason for recall

A small piece of the stylet sheath has the potential to shear off upon removal of the stylet from the tracheal tube.

Action taken

URGENT: PRODUCT RECALL letters dated December 23, 2014 were sent to all customers of record. The letters included instructions for customers to: 1) quarantine the affected product; 2) notify any customers whom you may have distributed the affected product to; 3) contact the appropriate Customer Service group to arrange for return and credit of any affected product in your inventory; and, 4) complete and return the enclosed Acknowledgement Form. Customers with questions about this recall can contact Cardinal Health Quality Systems at 800-292-9332.

Root cause

Process control

Status

Terminated

Product code

BSR

Quantity affected

104,432 stylets

Distribution

US: Nationwide (AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, WV, WY) + District o

Date initiated

2014-12-23

Date posted

2015-02-04

Date terminated

2016-08-01

Location

Waukegan, IL