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Pleur-Evac Adult-Ped Wet, LF Intl Eng, product code: A-8000I - Product Usage: CHEST DRAINAGE: To ...

FDA Device Recall #Z-2748-2020 — Class II — June 30, 2020

Recall Summary

Recall Number Z-2748-2020
Classification Class II — Moderate risk
Date Initiated June 30, 2020
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm TELEFLEX MEDICAL INC
Location Morrisville, NC
Product Type Devices
Quantity 204644 each (OUS)

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¿

Distribution Pattern

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.

Lot / 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

Other Recalls from TELEFLEX MEDICAL INC

Recall # Classification Product Date
Z-1126-2022 Class II (1) Gibeck Humid-Vent 2S Flex DC, Product #1773... Apr 11, 2022
Z-1127-2022 Class II (1) Teleflex Flex tube, Product #20011, sterile... Apr 11, 2022
Z-0628-2022 Class I 5 Fr. X 65 cm Arrow-Trerotola PTD Kit, Percutan... Jan 11, 2022
Z-0625-2022 Class I Arrow-Trerotola Over-The-Wire PTD Kit, Percutan... Jan 11, 2022
Z-0623-2022 Class I Arrow-Trerotola Over-The-Wire PTD Kit, Percutan... Jan 11, 2022

Frequently Asked Questions

Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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