PneumoDart, 14 ga x 3.25in., REF TM-317 A compact, sterile, device intended for the introduction into the body to facili

FDA device recall Z-0930-2020 · posted 2020-02-12 · Terminated

Recall details

Recalling firm

Tytek Medical Inc

Reason for recall

A defect involving an occluded needle was discovered during a training exercise.

Action taken

On November 15, 2019, Tytek Medical issued an Urgent Medical Device Recall notices and Return Response forms to customers. Customers were advised to take the following actions: 1) Please do not use any of the product from the affected lot. 2) Please recall this product from your points of distribution and return it immediately. 3) Product may be returned to Tytek Medical via UPS Account # R5513V or DHL Account # 958855282 to: Tytek Medical 4700 Ashwood Drive Ste 445, Cincinnati, OH 45241; (513) 874-7326 4) Complete and return the Instructions for Acknowledgement form via fax to (513) 874-7294; or via email to Stacey@tytekgroup.com Customers with questions or concerns may call (513) 872-7326 Monday through Friday 8 am - 5 pm, EST.

Root cause

Process control

Status

Terminated

Product code

BWC

Quantity affected

3,565 units

Distribution

US (nationwide), and countries of: Europe, Australia and Hong Kong.

Date initiated

2019-11-15

Date posted

2020-02-12

Date terminated

2020-10-01

Location

Blue Ash, OH