Z-2749-2020Class II

Pleur-Evac Adult-Ped Wet, LF Eng/Spanish

Name: Z-2749-2020 Pleur-Evac Adult-Ped Wet, LF Eng/Spanish
Creator: Teleflex Medical Inc
Published: 2020-06-30
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2020-06-30 / Terminated / root cause: packaging

FDA source

TELEFLEX MEDICAL INC began a recall of Pleur-Evac Adult-Ped Wet, LF Eng/Spanish, product code: A-8000I-06 - Product Usage: CHEST DRAINAGE: To evacuate air and/or fluid from the chest cavity or... on 2020-06-30. FDA classified it as Class II and gives the reason as "Potential for sterile packaging to be compromised". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2749-2020
Classification: Class II
Status: Terminated
Initiated: 2020-06-30
Posted: 2020-08-03
Terminated: 2026-07-02
Recalling firm: Teleflex Medical
Product: Pleur-Evac Adult-Ped Wet, LF Eng/Spanish, product code: A-8000I-06 - Product Usage: CHEST DRAINAGE: To evacuate air and/or fluid from the chest cavity or mediastinum. To help prevent air and/or fluid from re-accumulating in the chest cavity or mediastinum. To help re-establish and maintain normal intra-thoracic pressure gradients. To facilitate complete lung re-expansion to restore normal breathing dynamics.
Product code: KDQ Bottle, Collection, Vacuum
Reason for recall: Potential for sterile packaging to be compromised
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: On 6/30/2020, Teleflex issued the Urgent recall notification. The notification states the following action to be taken: 1. Immediately discontinue distribution and quarantine any products with the product code and lot number listed. 2. Using the provided customer letter and recall acknowledgement form templates, communicate this recall to any of your customers who have received product included within the scope of the recall. 3. Have the customers return any affected product to you, together with a completed Recall Acknowledgement Form, for consolidation and return to Teleflex Medical. In the event that an alternative approach is needed, contact Teleflex Medical Customer Service for more information at 1-866-396-2111. 4. To return recalled products to Teleflex Medical, complete the enclosed 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 product to Teleflex Medical. 5. Once you have completed returning all of the recalled products from your own inventory, and collecting and consolidating all of the recalled products from your customers, please check the box on the enclosed Recall Acknowledgment Form that indicates that you have completed the recall and fax it to 1-855-419-8507, Attn: Customer Service, or email it to [email protected]. 6. If you and your customers have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to [email protected].
Quantity in commerce: 1812 each (US)
Distribution: Worldwide distribution - US Nationwide distribution including in the states of FL, PR and the countries of AL, BR, CR, EC, ES, GB, GR, HK, HN, ID, IT, MX, PA, PE, PH, PK, PR, SG, SV, VE.
Product codes and lots: Lot Numbers: 74A1801125 74A1902739 74A2000267 74A2000268 74A2000745 74A2000746 74A2000747 74A2001170 74A2001171 74A2001934 74A2001935 74A2001936 74B1800758 74B2000067 74B2000068 74B2000363 74B2000364 74C1800921 74C1801541 74C1900767 74C1902202 74C2000217 74C2000474 74C2001737 74C2001769 74C2001770 74D1700243 74D1801534 74D1802402 74D1902703 74E1701799 74E1900882 74E1901526 74F1500554 74F1500555 74F1500731 74F1700647 74F1700648 74F1702092 74F1900390 74F1900391 74F1901723 74G1600770 74G1601461 74G1801221 74G1900713 74H1502743 74H1502805 74H1800551 74H1802708 74H1802709 74H1900252 74H1901558 74J1500223 74J1500904 74J1502363 74J1800509 74J1802225 74J1802226 74J1900253 74J1901144 74J1901636 74K1500375 74K1500917 74K1501031 74K1502282 74L1500196 74L1500197 74L1500198 74L1801592

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2749-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2748-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-12	2020-08-03
Z-2749-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-12	2020-08-03

Product code KDQ

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)