Avanos BALLARD Closed Suction System mislabeled for DEHP content
Certain lots of AVANOS BALLARD Closed Suction System for Adults were labeled as DEHP-free but contain DEHP in tubing components. These units are used for mechanical ventilation and distributed in the US and South Africa.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves FDA Class II devices with mislabeling of a regulated chemical (DEHP). Although no illnesses or injuries have been reported, this represents a risk-of-harm scenario for vulnerable patients on mechanical ventilation.
Plain-English summary
Avanos Medical, Inc. is recalling certain lots of the BALLARD Closed Suction System for Adults (14 Fr, Product code 221038). These units were labeled as not being made with Di(2-ethylhexyl) phthalate (DEHP), but the tubing components were found to contain DEHP.
DEHP is a regulated chemical in medical devices. Patients on mechanical ventilation using the affected closed suction systems may potentially be exposed to DEHP through the device.
Approximately 4,730 cases (94,600 devices) are affected, distributed in the United States and South Africa. The recalled lot numbers are: 30112716, 30122936, 30116495, 30122179, 30116496, 30124942, 30117487, 30126227, 30117488, 30124946, 30117632, 30127429, 30117633, 30127494, 30113925, 30137504, 30119101, 30153170, 30119102, 30151042, 30116223, 30194152, and 30123991.
The recalled product
- Product
- AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product code 221038, provide suction on patients on mechanical ventilation
- Manufacturer
- Avanos Medical, Inc.
- Hazard
- dehp-exposure
- mis-labeling
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI/DI 00609038945064
- Lot Numbers: 30112716
- 30122936
- 30116495
- 30122179
- 30116496
- 30124942
- 30117487
- 30126227
- 30117488
- 30124946
- 30117632
- 30127429
- 30117633
- 30127494
- 30113925
- 30137504
- 30119101
- 30153170
- 30119102
Distribution
Distribution scope not specified by the agency.
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