ICU Medical 32" (81 cm) Appx 4.4 mL, 20 Drop Blood Set w/200 Micron Filter, Rotating Luer recall — FDA Z-2610-2018
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
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The newest recall records with useful source details are listed here.
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.
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.
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.
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.
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.
INOmeters affixed to the INOflo cylinders in Lot 17FP-0570 were programmed with an incorrect expiration date (11/2017). For Lot 17FP-0570, the label affixed to each INOflo cylinder has the…
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.
Browse recent months with enough recall history for useful comparison.