Recall archive
5 recalls · page 1 of 1
Reported Jan 22, 2020
Medline Thermistor Foley Catheter 14 FR 5-10 ml, non sterile Catalog Number: 102201101463MD {Medline code 55346)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Degania Silicone, Ltd.
Matched: Brand — Temperature deviation did not meet release specifications
FDA (openFDA device enforcement)
Reported Aug 21, 2019
Cardinal Health Jackson-Pratt Channel Drain 15FR Cardinal PN:JP-2223 An introduction/drainage catheter is a device that…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Degania Silicone, Ltd.
Matched: Brand — 15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile…
7 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 26, 2018
Temperature sensor Foley catheter 18FR, Catalogue Number 102205101880AB Product Usage: This is sterile, single use,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Degania Silicone, Ltd.
Matched: Brand · Product details — The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body…
31 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 14, 2018
Silicone Fluted Round Drain 24Fr (hubless) & Connector, Sterile. Catalog Number JP-2234. Used for the drainage of body…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Degania Silicone, Ltd.
Matched: Brand · Product · Product details — Sterile pouches are missing labels on them. The boxes themselves are properly labeled. The issue is related to the production lot P1607442 only.
FDA (openFDA device enforcement)
Reported Mar 1, 2017
Jackson-Pratt Channel Drain Silicone Round, Fully Fluted w/10FR Trocar. Sterile. Rx Distributed by Cardinal Health, USA…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Degania Silicone, Ltd.
Matched: Brand · Product · Product details — Product sterility compromised due to breach of sterile barrier
FDA (openFDA device enforcement)
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