Reported Dec 6, 2023 · Ongoing
TruWave Pressure monitoring set, REF: PX212: cc/12 in (30cm), PX260: (3 cc/60in (150cm), PX272: 3 cc/72in (180cm),…
Edwards Lifesciences, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Edwards Lifesciences, LLC · 1 Edwards Way · Irvine, CA · 92614-5688
Is this the product you have?
- TruWave Pressure monitoring set
- REFPX212: cc/12 in (30cm)
- PX260(3 cc/60in (150cm)
- PX2723 cc/72in (180cm)
- PX2843 cc/84 in (210 cm)
- PX2X2x2 (3cc)
- PX3X3284CX3 (3cc)
- PX4X4
x4 (3cc)PX600F (3cc)
- PXMK1876x 3 (3 cc)
- PXMK1940(3 cc)
- PXMK2024(3cc)/77 in (196cm)
- PXMK2041(3 cc)
- PXMK2321(3cc)/48in (122cm)
- PXMK2331x4 (3cc)/12 in (30cm)
- PXMK9146x 2 (3cc)
- PXMK1876x3(3cc)
- PXVK1099(3cc)/62in (157cm)
- PXMK0102x2 (3cc)/84in (213cm)
- PXMK2043X3(3CC)
- T001657Ax2 (3cc)/210cm
- T001658Ax2 (3cc)/180 cm
- T001660AX3 (3CC)/150CM
- T001709AX2 (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
- Lot codes and dates
24 of 24 products
Products covered by this recall # Barcodes Product as published 1 07460691950221UDI: 07460691950221/Lot # 65087613 2 07460691950191PX260: UDI: 07460691950191/Lot #64817892, 64818036, 64818038, 64964776, 64964780 3 0746069195020707460691950214PX272: UDI: 07460691950207/Lot # 65067588 PX284: UDI: 07460691950214/Lot # 64980120, 64980121, 65008760, 65019888, 65019889, 65035079 4 07460691950061PX2X2: UDI: 07460691950061/Lot # 64955114, 65012789, 65027868, 65170585 5 07460691950269PX3X3284C:UDI: 07460691950269/Lot # 64906878, 65007202, 65019845 6 07460691950665PX4X4: UDI: 07460691950665/Lot # 64807960, 64835551, 64858629 7 07460691945555PX600F: UDI: 07460691945555/Lot # 64918553, 64951413, 65016989 8 07460691953826PXMK1876: UDI: 07460691953826/Lot # 64817828, 64817963 9 07460691955981PXMK1940: UDI: 07460691955981/Lot # 64858039 10 07460691958180PXMK2024: UDI: 07460691958180/Lot # 64964690 11 07460691951464PXMK2041: UDI: 07460691951464/Lot # 64933443, 64933444 12 07460691958784PXMK2321: UDI: 07460691958784/Lot # 64912231 13 07460691959224PXMK2331: UDI: 07460691959224/Lot # 64933498 14 07460691954427PXMK9146: UDI: 07460691954427/Lot # 64992075 15 07460691953826PXMK1876: UDI: 07460691953826/Lot # 64817963 16 07460691958753006901031999320746069195623007460691902046PXVK1099: UDI: 07460691958753 /Lot # 65067568 PXMK0102: UDI: 00690103199932/ Lot # 65008741 PXMK2043: UDI: 07460691956230/ Lot # 64980031 T001657A: UDI: 07460691902046/Lot# 64686945, 64807966, 64918558, 64948620 17 07460691902053T001658A :UDI: 07460691902053/Lot #65007203, 65036124 18 07460691902077T001660A: UDI: 07460691902077/Lot # 64964732, 65019857 19 07460691947610T001709A: UDI: 07460691947610/Lot# 64918560, 64964727, 65079483 20 07460691947306T001767A: UDI: 07460691947306/Lot # 64891376, 64906871, 64980035, 64983290, 65035029 - Amount recalled
- 118,570 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Edwards Lifesciences, LLC recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.