Recall Z-0930-2020 ยท BWC Needle, Emergency Airway
Tytek Medical Inc
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.
| Date | Feb 12, 2020 (initiated Nov 15, 2019) |
| Status | Terminated |
| Reason | A defect involving an occluded needle was discovered during a training exercise. |
| Root cause | 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- |
| Quantity | 3,565 units |
| Distribution | US (nationwide), and countries of: Europe, Australia and Hong Kong. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.