TELEFLEX MEDICAL INC 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. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
TELEFLEX MEDICAL INC
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Lot Numbers: 74A1801125 74A1902739 74A2000267 74A2000268 74A2000745 74A2000746 74A2000747 74A2001170 74A2001171 74A2001934 74A2001935 74A2001936 74B1800758 74B2000067 74B2000068 74B2000363 74B2000364 74C1800921 74C1801541 74C1900767 74C1902202 74C2000217 74C2000474 74C2001737 74C2001769 74C2001770 74D1700243 74D1801534 74D1802402 74D1902703 74E1701799 74E1900882 74E1901526 74F1500554 74F1500555 74F1500731 74F1700647 74F1700648 74F1702092 74F1900390 74F1900391 74F1901723 74G1600770 74G1601461 74G1801221 74G1900713 74H1502743 74H1502805 74H1800551 74H1802708 74H1802709 74H1900252 74H1901558 74J1500223 74J1500904 74J1502363 74J1800509 74J1802225 74J1802226 74J1900253 74J1901144 74J1901636 74K1500375 74K1500917 74K1501031 74K1502282 74L1500196 74L1500197 74L1500198 74L1801592
TELEFLEX MEDICAL INC is recalling Pleur-Evac Adult-Ped Wet, LF Eng/Spanish, product code: A-8000I-06 - Product Usage: CHEST DRAINAGE: due to Potential for sterile packaging to be compromised. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for sterile packaging to be compromised
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026