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U.S. Department of Health and Human Services

Class 1 Device Recall PneumoDart

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  Class 1 Device Recall PneumoDart see related information
Date Initiated by Firm November 15, 2019
Date Posted February 12, 2020
Recall Status1 Terminated 3 on October 01, 2020
Recall Number Z-0930-2020
Recall Event ID 84296
Product Classification Needle, emergency airway - Product Code BWC
Product PneumoDart, 14 ga x 3.25in., REF TM-317

A compact, sterile, device intended for the introduction into the body to facilitate the removal of air from the pleural cavity as a result of a tension pneumothorax condition.
Code Information NSN 6515-01-655-9514 Lot number - 190524J69 Expiration Date - May 24, 2026
Recalling Firm/
Manufacturer		 Tytek Medical Inc
4700 Ashwood Dr Ste 445
Blue Ash OH 45241-2684
For Additional Information Contact Stacey Cremers
513-874-7326
Manufacturer Reason
for Recall		 A defect involving an occluded needle was discovered during a training exercise.
FDA Determined
Cause 2		 Process control
Action 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.
Quantity in Commerce 3,565 units
Distribution US (nationwide), and countries of: Europe, Australia and Hong Kong.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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