Z-2922-2020Class II

Pleur-evac Thoracic Catheters Catalog No: DTRC-20S The thoracic catheter is indicated to be used in any...

Name: Z-2922-2020 Pleur-evac Thoracic Catheters Catalog No: DTRC-20S The thoracic catheter is indicated to be used in any...
Creator: Teleflex Medical Inc
Published: 2020-08-07
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2020-08-07 / Terminated / root cause: sterility

FDA source

TELEFLEX MEDICAL INC began a recall of 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... on 2020-08-07. FDA classified it as Class II and gives the reason as "Potential sterility issue". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-2922-2020
Classification: Class II
Status: Terminated
Initiated: 2020-08-07
Posted: 2020-08-28
Terminated: 2023-01-14
Recalling firm: Teleflex Medical
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.
Product code: GBX Catheter, Irrigation
Reason for recall: Potential sterility issue
Root cause tag: sterility
FDA 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 [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.
Quantity in commerce: 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
Product codes and lots: 74K1900074 74K1901335 74L1901435 74M1900809

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2922-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2922-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-09	2020-08-28

Product code GBX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)