Hudson RCI Pediatric Anesthesia Breathing Circuits, Single Patient Use, Rx Only, Product Usage: To administer medical ga

FDA device recall Z-2714-2014 · posted 2014-09-30 · Terminated

Recall details

Recalling firm

Teleflex Medical

Reason for recall

The pediatric breathing circuits can crack prior to and during use.

Action taken

Teleflex Medical sent an Urgent Medical Device Recall dated September 8, 2014, to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to immediately discontinue use, quarantine any products with the product codes and lot numbers provided in the notification, return any affected product, complete and return the enclosed Recall Acknowledgement Form and fax it to the attention of Customer Service. For questions contact your local sales representative or Customer Service at 1-866-246-6990.

Root cause

Device Design

Status

Terminated

Product code

CAI

Quantity affected

27,176 units

Distribution

Worldwide Distribution - US Nationwide in the states of AZ, CA, FL, IL, KY, OH, NJ, NY, TX, LA, OR, SD, WA, including Puerto Rico, and the countries of Belgium, Canada, Chile, China, Colombia, Korea,

Date initiated

2014-09-08

Date posted

2014-09-30

Date terminated

2016-08-16

Location

Durham, NC