Recall Z-2748-2020 ยท KDQ Bottle, Collection, Vacuum
TELEFLEX MEDICAL INC
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 dyna
| Date | Jun 30, 2020 |
| Status | Terminated |
| Reason | Potential for sterile packaging to be compromised |
| 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 t |
| Quantity | 204644 each (OUS) |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.