Recall Z-2922-2020
Teleflex Medical Inc · initiated August 7, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: 74K1900074 74K1901335 74L1901435 74M1900809
Reason for recall
Potential sterility issue
FDA-determined cause: Under Investigation by firm
Action taken
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 instructions for the return of products to Teleflex Medical. 3. If you have no affected stock, please complete the Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. If you have any question please contact locals representative or Customer Service at 1-866-396-2111.
Details
- Recall number
- Z-2922-2020
- Initiated
- August 7, 2020
- Terminated
- January 14, 2023
- Product code
- GBX – Catheter, Irrigation
- 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
- Recalling firm
- Teleflex Medical Inc, Morrisville, NC