4001PS Neonatal/Paed.Intubation Kit 2.5mm Murphy, LDS 15mm Conn Pediatric Endotracheal Intubation Kit

FDA device recall Z-2536-2014 · posted 2014-08-28 · Terminated

Recall details

Recalling firm

Smiths Medical ASD, Inc.

Reason for recall

The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or difficulty when passing a suction catheter.

Action taken

Smiths Medical sent an Urgent Medical Device Recall Notice dated July 11, 2014, to all affected customers. The letter informed customers of the recall and instructed them to inspect their inventory and segregate any unused affected products and to complete and return the Recall Confirmation Form, by Fax 1-800-621-2590 or email to endotrachealtubeholders@smiths-medical.com. Customers with questions were instructed to call Smiths Medical's Customer Service Department at 1-800-258-5361. For questions regarading this recall call 866-216-8806.

Root cause

Process change control

Status

Terminated

Product code

BTR

Quantity affected

135,518 (110,246 nationwide)

Distribution

Worldwide Distribution - USA including AK, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, W

Date initiated

2014-07-07

Date posted

2014-08-28

Date terminated

2021-05-26

Location

Keene, NH

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