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Terminated

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.

FDA Recall Z-2922-2020 · Posted None

Recalling FirmTELEFLEX MEDICAL INC
Recall StatusTerminated
Product CodeGBX
Date Initiated2020-08-07
Date Terminated2023-01-14
Product Quantity700 eaches

Reason for Recall

Potential sterility issue

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 [email protected]. 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 [email protected]. If you have any question please contact locals representative or Customer Service at 1-866-396-2111.

Root Cause

Under Investigation by firm

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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