Z-0360-2024 Class II Ongoing
FDA device recall Z-0360-2024 was initiated by Avanos Medical, Inc. on October 13, 2023 and is designated Class II. Reason for recall: Certain lots of BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI were labeled as not being made with Di(2-ethylhexyl) phthalate (DEHP); however, Avanos has determined that the tubing componen… The recall status is ongoing. Affected quantity: 4730 cases (94600 devices).
Recall Details
- Product Type
- Devices
- Report Date
- November 29, 2023
- Initiation Date
- October 13, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4730 cases (94600 devices)
Product Description
AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product code 221038, provide suction on patients on mechanical ventilation
Reason for Recall
Certain lots of BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI were labeled as not being made with Di(2-ethylhexyl) phthalate (DEHP); however, Avanos has determined that the tubing components of the product did contain DEHP.
Distribution Pattern
US and South Africa
Code Information
UDI/DI 00609038945064, Lot Numbers: 30112716, 30122936, 30116495, 30122179, 30116496, 30124942, 30117487, 30126227, 30117488, 30124946, 30117632, 30127429, 30117633, 30127494, 30113925, 30137504, 30119101, 30153170, 30119102, 30151042, 30116223, 30194152, 30123991