PlainRecalls
FDA Devices Moderate Class II Ongoing

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.

Reported: August 12, 2020 Initiated: June 30, 2020 #Z-2749-2020

Product Description

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.

Reason for Recall

Potential for sterile packaging to be compromised¿

Details

Recalling Firm
TELEFLEX MEDICAL INC
Units Affected
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.
Location
Morrisville, NC

Frequently Asked Questions

What product was recalled?
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.. Recalled by TELEFLEX MEDICAL INC. Units affected: 1812 each (US).
Why was this product recalled?
Potential for sterile packaging to be compromised¿
Which agency issued this recall?
This recall was issued by the FDA Devices on August 12, 2020. Severity: Moderate. Recall number: Z-2749-2020.