DeRoyal Industries Custom medical procedure packs labeled as: a) CATH ANGIOGRAPHY DRAPE recall — FDA Z-2090-2023
The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
Complete FDA and NHTSA recall records dated in 2023, 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.
The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
A firmware error may lead to an incorrect association of test result(s) to a sample ID and therefore to an incorrect patient result. The mis-association of test results, or a delay in…
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
1. Wheels loosening over time with use of the device could lead to the inability to effectively drive the device and could lead to delay in patient treatment. 2.Batteries used to power the…
Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due to friction with the drill bit.Risk to patients includes…
Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due to friction with the drill bit.Risk to patients includes…
Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due to friction with the drill bit.Risk to patients includes…
The devices were manufactured with the pin sleeve holes too narrow, which does not allow the pin sleeves to pass through the pin sleeve holes, thereby preventing pin placement through the…
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due to friction with the drill bit.Risk to patients includes…
undeclared peanuts
Undeclared almonds and/or undeclared wheat
Product may be contaminated with Salmonella
May contain trace amounts of undeclared milk
Product may be contaminated with Salmonella
Product may be contaminated with Salmonella
Romaine lettuce may be contaminated with deer feces.
Potential glass quality issue that may result in glass chips in the product
Due to over pressurization, can may fail/explode.
Potential for foreign material (metal).
Potential for foreign material (metal).
May contain trace amounts of undeclared milk
Undeclared almonds and/or undeclared wheat
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.