FDA (Devices) recall action 98907
The FDA (Devices) publishes a recall like this one as 20 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 20 pages.
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
CORFLO Safety PEG Kits, catalog number 30-5320, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall. 61 kits are affected.
MIC Safety PEG Kits, 14 Fr PULL, catalog number 7180-14, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall. 208 kits affected.
CORFLO Safety PEG Kits with ENFit Connector, catalog number 50-6312, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall. 43 kits affected.
MIC Safety PEG Kits with ENFit Connectors, 24 Fr PULL, catalog number 8180-24, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall.
MIC Safety PEG Kits with ENFit Connectors, 14 Fr PULL, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall for quality issues.
MIC Safety PEG Kits with ENFit Connectors, 24 Fr PUSH OTW, catalog number 8170-24, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall.
MIC Safety PEG Kits, 24 Fr PUSH OTW, catalog number 7170-24, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall. 132 kits affected.
MIC Safety PEG Kits, 14 Fr PUSH OTW, catalog number 7170-14, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall. 22 kits affected.
MIC Safety PEG Kits, 20 Fr PULL, catalog number 7180-20, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall. 3,184 kits affected.
MIC Safety PEG Kits, 20 Fr PUSH OTW, catalog number 7170-20, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall. 901 kits affected.
CORFLO Safety PEG Kits with ENFit Connector, catalog number 50-6316, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall. 54 kits affected.
CORFLO Safety PEG Kits with ENFit Connector, catalog number 50-4320, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall. 49 kits affected.
MIC Safety PEG Kits with ENFit Connectors, 20 Fr PUSH OTW, catalog number 8170-20, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall.
MIC Safety PEG Kits, 24 Fr PULL, catalog number 7180-24, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall. 1,006 kits affected.
CORFLO Safety PEG Kits, catalog number 30-4320, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall. 231 kits are affected.
CORFLO Safety PEG Kits, catalog number 30-6312, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall. 31 kits are affected.
CORFLO Safety PEG Kits, catalog number 30-6316, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall. 41 kits are affected.
MIC Safety PEG Kits with ENFit Connectors, 14 Fr PUSH OTW, catalog number 8170-14, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall.
CORFLO Safety PEG Kits with ENFit Connector, catalog number 50-5320, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall. 72 kits affected.
MIC Safety PEG Kits with ENFit Connectors, 20 Fr PULL, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall for quality issues. 6,005 kits affected.