Recall Z-2922-2020 ยท GBX Catheter, Irrigation
TELEFLEX MEDICAL INC
Pleur-evac Thoracic Catheters Catalog No: DTRC-20S The thoracic catheter is indicated to be used in any surgical procedure requiring attachment to a Chest Drainage device. The thoracic catheter is indicated for use less than 30 days.
| Date | Aug 7, 2020 |
| Status | Terminated |
| Reason | Potential sterility issue |
| Root cause | Under Investigation by firm |
| Action | Teleflex issued an "Urgent Medical Device Recall" notification on August 7, 2020. It states the following actions to be taken: 1. If you have affected stock in inventory, immediately discontinue use and quarantine any products with the product code and lot number listed, so that the affected products can be returned to Teleflex. 2. To return product, complete the Recall Acknowledgement Form and fax it to 1-855- 419-8507, Attn: Customer Service or email to recalls@teleflex.com. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide i |
| Quantity | 700 eaches |
| Distribution | US Distribution of states to: AR AZ CA CO FL GA IA IL IN LA MI MN MS NC NH NV NY OH OK OR PA SD TN TX VA WA WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.