
Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP
Potential for thrombus formation during prolonged use of the introducer.
Page 7 of 40 · 1,986 total recalls

Potential for thrombus formation during prolonged use of the introducer.

Potential for thrombus formation during prolonged use of the introducer.

Potential for thrombus formation during prolonged use of the introducer.

Ingredient statement declares eggs, but eggs are omitted from the "contains" allergen statement on the product labels.

Undeclared allergen, sesame.

Ingredient statement declares eggs, but eggs are omitted from the "contains" allergen statement on the product labels.

Devices containing inner shaft assemblies from specific manufacturing lots may have an increased potential for...

Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the...

Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the...

Product is potentially contaminated with foreign material (plastic particles).

Microbial contamination of sterile products

Undeclared colors (FD&C Yellow 5 and FD&C Red 40).

There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient...

There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient...

There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient...

There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient...

Product requires refrigeration but the label is missing a "Keep Refrigerated" statement

Foreign material found in product (identified as metal shavings)

Defective container:may contain bottles with incomplete seals

Defective container:may contain bottles with incomplete seals

Defective container:may contain bottles with incomplete seals

Defective container:may contain bottles with incomplete seals


Defective container:may contain bottles with incomplete seals

Defective container:may contain bottles with incomplete seals

Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a...

Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a...

Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a...

Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a...

Undeclared egg

External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being...

External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being...

External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being...

Contains undeclared allergen (shrimp).

Undeclared FD&C Red 40

cGMP deviations

Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases,...

Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan

Potential for Salmonella

Potential for Salmonella

Product tested positive for Salmonella

Subpotent Drug

Lack of Assurance of Sterility


Expansion of RES 98277. Specific lots of reprocessed catheters may contain small particles of residual material. If...

Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
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