ICU Medical 105" (267 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Pre-Slit Port recall — FDA Z-2635-2018
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
Complete FDA and NHTSA recall records dated in 2018, organized for browsing by month, category and recalling company.
Select a month to review the recall records reported during that period.
Records are ordered by the best available source date.
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
An error in manufacturing of the AirLife Resuscitation Devices that has the potential to obstruct airflow of the supplemental oxygen delivery during use.
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
Potential for control line not appearing on the test strip
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
The spreader bar can detach from the scale attachment under certain conditions.
Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.