Class 2 Device Recall PleurEvac

• Date Initiated by Firm: June 30, 2020
• Create Date: August 03, 2020
• Recall Status: Open, Classified
• Recall Number: Z-2748-2020
• Recall Event ID: 85952
• Product Classification: Bottle, collection, vacuum - Product Code KDQ
• 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.
• Code Information: Lot Numbers: 74A1602932 74A1703007 74A1802909 74A1900358 74A2001172 74A2002639 74B1600856 74B1600857 74B1700269 74B1701278 74B1702684 74B1801734 74B1900875 74B1901993 74B1902825 74B2000066 74B2000361 74C1700392 74C1701906 74C1703150 74C1801547 74C1801548 74C2000213 74C2000214 74C2000473 74C2000754 74C2002285 74D1600915 74D1800630 74D1800632 74D1900143 74D1900144 74D1902087 74E1600936 74E1700397 74E1701189 74E1701196 74E1702207 74E1800301 74E1801286 74E1802464 74E1900510 74E1901525 74F1502198 74F1600345 74F1600460 74F1600461 74F1603155 74F1702091 74F1702491 74F1800692 74F1802178 74F1901722 74G1601816 74G1602512 74G1700142 74G1701822 74G1801551 74G1900712 74G1901738 74G1902569 74H1602162 74H1602618 74H1701206 74H1703208 74H1801031 74H1802122 74H1900242 74H1900251 74H1902213 74J1500448 74J1500865 74J1600969 74J1700548 74J1702261 74J1703038 74J1800939 74J1801384 74J1801385 74J1902581 74K1500387 74K1502281 74K1600247 74K1601780 74K1700695 74K1701305 74K1701886 74K1801271 74K1801272 74K1900069 74K1902094 74L1600158 74L1602510 74L1800465 74L1800953 74L1801262 74L1901155 74L1901156 74L1901427 74L1901428 74L1902305 74L1902306 74M1600558 74M1700229 74M1800724 74M1801532
• Recalling Firm/ Manufacturer: TELEFLEX MEDICAL INC; 3015 Carrington Mill Blvd; Morrisville NC 27560-5437
• For Additional Information Contact: Teleflex Customer Service; 866-396-2111
• Manufacturer Reason for Recall: Potential for sterile packaging to be compromised¿
• FDA Determined 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 recalls@teleflex.com. 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 recalls@teleflex.com. 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 recalls@teleflex.com.
• Quantity in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.