REF 0038460 Toomey Syringe 70cc Syringe with Catheter Tip and Luer Tip Adapters, Single Use, Rx Only, Latex Free, 50 uni

FDA device recall Z-0812-2016 · posted 2016-02-16 · Terminated

Recall details

Recalling firm

C.R. Bard, Inc.

Reason for recall

Report by a customer of an open package seal.

Action taken

BMD sent an Urgent Medical Product Recall letter to each of the customers via FedEx with proof of delivery notice. The leter identified the affected product, problem and actions to be taken. All consignees were instructed to carry out the recall to the user level. The letter included a Recall and Effectiveness Check Form which was to be returned to Bard.

Root cause

Packaging process control

Status

Terminated

Product code

KYZ

Quantity affected

15,400 units

Distribution

US Nationwide Distribution - in the states of: AL, AZ, CA, CO, FL, GA, IL, IN, IA, KS, KY, LA, MD, MI, MS, MO, NE, NV, NJ, NM, NY, NC, OH, OK, PA, SC, TN, TX, VA, WA, WV, and Puerto Rico

Date initiated

2016-01-04

Date posted

2016-02-16

Date terminated

2017-06-06

Location

Covington, GA