Z-0413-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 6, 2023
- Initiation Date
- October 4, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 118,570 units
Product 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,
Reason for Recall
Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
Distribution Pattern
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
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;