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.
FDA Recall Z-0930-2020 · Posted 2020-02-12
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Recalling FirmTytek Medical Inc
Recall StatusTerminated
Product CodeBWC
Date Initiated2019-11-15
Date Terminated2020-10-01
Product Quantity3,565 units
Reason for Recall
A defect involving an occluded needle was discovered during a training exercise.
Firm 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 [email protected]
Customers with questions or concerns may call (513) 872-7326 Monday through Friday 8 am - 5 pm, EST.
Root Cause
Process control
Distribution Pattern
US (nationwide), and countries of: Europe, Australia and Hong Kong.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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