Recall archive
4 recalls · page 1 of 1
Reported Feb 5, 2020
Custom Healthcare Systems, Inc. Inpatient Dialysis Kit PAK-19244. Single use. Dialysis kit
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Custom Healthcare Systems, Inc.
Matched: Brand · Product · Product details — A component (1961 TELFA PAD 2 X 3) contains LATEX and was used in the Medical Convenience Kit(PAK-19244). Case label and device label for product did…
FDA (openFDA device enforcement)
Reported Oct 31, 2018
CHS Custom Convenience Kit-DR. NANDA CLOSING TRAY(CONMED HYFRECATOR SHARP) Product Number: B9-15934B
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Custom Healthcare Systems, Inc.
Matched: Brand · Product · Product details — Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
28 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 29, 2015
Safety PICC Insertion Tray with Chloraprep OneStep - Model #5026CL-9 - 12 pr case. Packaged for Physician use only.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Custom Healthcare Systems, Inc.
Matched: Brand — An INCORRECT item number is packed within the OUTSIDE "PIGGYBACKED" PACKAGE. The interior sealed STERILE KIT is correct and NO adverse issues affect…
FDA (openFDA device enforcement)
Reported Feb 13, 2013
Custom Breast Biopsy Tray, Catalog # B 9-16261, packaged in bags, 1 tray/bag, 20 bags/case. Product Usage: A sterile…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Custom Healthcare Systems, Inc.
Matched: Brand · Product · Product details — Surgical procedure trays are packed with pharmaceuticals for injection that may contain particulate matter.
1 more product in this recall
FDA (openFDA device enforcement)
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