Recall Z-2748-2020— TELEFLEX MEDICAL INC
Class II · Ongoing
Class II FDA medical device recall by TELEFLEX MEDICAL INC, initiated 2020-06-30. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Potential for sterile packaging to be compromised¿.
- Recalling firm
- TELEFLEX MEDICAL INC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2020-06-30
- Firm location
- Morrisville, NC, United States
Product description
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.
Reason for recall
Potential for sterile packaging to be compromised¿
Data sourced from openFDA. This site is unofficial and independent of the FDA.