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,

Class I - Dangerous

🏥 Medical Devices Recalled: October 4, 2023 Edwards Lifesciences Diagnostic Equipment Nationwide

What Should You Do?

Check if you have this product:
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;
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Edwards Lifesciences, LLC
Reason for Recall:: Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: ongoing

Product Information

Full Description:

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,

Product Codes/Lot Numbers:

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;