TELEFLEX MEDICAL INC recalls Pleur-Evac Adult-Ped Wet, LF Intl Eng, product code: A-8000I - Product Usage: CHEST DRAINAGE: To evacuate air and/or flu

Recalled August 12, 2020 · FDA recall Z-2748-2020 · TELEFLEX MEDICAL

Hazard

Potential for sterile packaging to be compromised¿ · FDA Class II

Units

204644 each (OUS)

Sold at

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.

Description

Potential for sterile packaging to be compromised¿

Product

Pleur-Evac Adult-Ped Wet, LF Intl Eng, product code: A-8000I - 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.

Manufacturer(s)

TELEFLEX MEDICAL INC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →