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U.S. Department of Health and Human Services

Class 2 Device Recall TruWave Pressure monitoring set

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  Class 2 Device Recall TruWave Pressure monitoring set see related information
Date Initiated by Firm October 04, 2023
Date Posted November 29, 2023
Recall Status1 Open3, Classified
Recall Number Z-0413-2024
Recall Event ID 93279
510(K)Number K142749  K171996  K183413  
Product Classification Transducer, blood-pressure, extravascular - Product Code DRS
Product TruWave Pressure monitoring set, REF: PX212: cc/12 in (30cm), PX260: (3 cc/60in (150cm), PX272: 3 cc/72in (180cm), PX284: 3 cc/84 in (210 cm), PX2X2: x2 (3cc), PX3X3284C: X3 (3cc), PX4X4: x4 (3cc), PX600F (3cc), PXMK1876: x 3 (3 cc), PXMK1940: (3 cc), PXMK2024: (3cc)/77 in (196cm),PXMK2041: (3 cc), PXMK2321: (3cc)/48in (122cm), PXMK2331: x4 (3cc)/12 in (30cm), PXMK9146: x 2 (3cc), PXMK1876: x3(3cc), PXVK1099:(3cc)/62in (157cm), PXMK0102: x2 (3cc)/84in (213cm), PXMK2043:X3(3CC), T001657A: x2 (3cc)/210cm, T001658A: x2 (3cc)/180 cm, T001660A: X3 (3CC)/150CM, T001709A: X2 (3 cc)/210 cm,T001767A: (3cc)/60in (150cm), T321573A: (3cc)/66 in (165cm), T433803A (3cc)/200cm, T441T01C: (3cc)/225 cm, T494C00B: (3 cc)/180 cm,
Code Information PX212: UDI: 07460691950221/Lot # 65087613; PX260: UDI: 07460691950191/Lot #64817892, 64818036, 64818038, 64964776, 64964780; PX272: UDI: 07460691950207/Lot # 65067588 PX284: UDI: 07460691950214/Lot # 64980120, 64980121, 65008760, 65019888, 65019889, 65035079; PX2X2: UDI: 07460691950061/Lot # 64955114, 65012789, 65027868, 65170585; PX3X3284C:UDI: 07460691950269/Lot # 64906878, 65007202, 65019845; PX4X4: UDI: 07460691950665/Lot # 64807960, 64835551, 64858629; PX600F: UDI: 07460691945555/Lot # 64918553, 64951413, 65016989; PXMK1876: UDI: 07460691953826/Lot # 64817828, 64817963; PXMK1940: UDI: 07460691955981/Lot # 64858039; PXMK2024: UDI: 07460691958180/Lot # 64964690; PXMK2041: UDI: 07460691951464/Lot # 64933443, 64933444; PXMK2321: UDI: 07460691958784/Lot # 64912231; PXMK2331: UDI: 07460691959224/Lot # 64933498; PXMK9146: UDI: 07460691954427/Lot # 64992075; PXMK1876: UDI: 07460691953826/Lot # 64817963; PXVK1099: UDI: 07460691958753 /Lot # 65067568 PXMK0102: UDI: 00690103199932/ Lot # 65008741 PXMK2043: UDI: 07460691956230/ Lot # 64980031 T001657A: UDI: 07460691902046/Lot# 64686945, 64807966, 64918558, 64948620; T001658A :UDI: 07460691902053/Lot #65007203, 65036124; T001660A: UDI: 07460691902077/Lot # 64964732, 65019857; T001709A: UDI: 07460691947610/Lot# 64918560, 64964727, 65079483; T001767A: UDI: 07460691947306/Lot # 64891376, 64906871, 64980035, 64983290, 65035029; T321573A: UDI: 07460691910270/Lot# 64807975; T433803A: UDI: 07460691926714/Lot # 64722635; T441T01C: UDI: 07460691928848/Lot # 64835565; T494C00B:UDI: 07460691950313/Lot #64807969, 64918562;
Recalling Firm/
Manufacturer		 Edwards Lifesciences, LLC
1 Edwards Way
Irvine CA 92614-5688
For Additional Information Contact Linnette Torres
949-250-6827
Manufacturer Reason
for Recall		 Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
FDA Determined
Cause 2		 Device Design
Action On 10/18/2023, Edwards Lifesciences issued a "Urgent: Medical device Correction Action via FedEx mail. Edwards ask consignees to take the following actions: 1. Follow the IFU for proper setup and flushing of your device. 2. Follow the instructions included in the enclosed customer acknowledgement form to complete the acknowledgement process. 3. Verify your inventory on the attached customer acknowledgement form. 3a.E-mail the completed form to Edwards Customer Service at US.FCA@edwards.com, within 15 days from receipt of this notification. 4. Distribute this notice within your organization or to any organization where the potentially impacted product has been transferred. 5. Please post a copy of this notice near and/or with affected devices. 6. Contact Edwards Customer Service at 1-888-352-0904 if you would like to return any of your devices or have further questions. 7. Action Requested for Distributors: In addition to the actions above, please forward this customer communication to any of your customers who have purchased the impacted product.
Quantity in Commerce 118,570 units
Distribution US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA WA WI WV WY OUS: Argentina Australia Austria Bahrain Belgium Brazil Canada CANARY ISLANDS Chile Colombia Costa Rica Czech Republic Denmark Ecuador Faroe Islands France Germany Greece Guatemala Hong Kong Indonesia Ireland Israel Italy Japan Malaysia Netherlands New Zealand Northern Ireland Norway Panama Poland Portugal Saudi Arabia Singapore Slovakia Slovenia South Korea Spain Sweden Switzerland United Arab Emirates (UAE) United Kingdom Vietnam
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.
510(K) Database 510(K)s with Product Code = DRS and Original Applicant = Edwards Lifeciences, LLC
510(K)s with Product Code = DRS and Original Applicant = Edwards Lifesciences, LLC
510(K)s with Product Code = DRS and Original Applicant = EDWARDS LIFESCIENCES, LLC.
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