Device recall: CRE Pro Wireguided 6-8mm 240cm
Potential sterile breach of the pouches in which devices are packaged. — Boston Scientific Corporation · Class II · Ongoing · 81,543 units
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Potential sterile breach of the pouches in which devices are packaged. — Boston Scientific Corporation · Class II · Ongoing · 81,543 units
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site. — Medline Industries, LP · Class II · Ongoing · 5,698 kits
Ventilator coaxial breathing circuit may have, expiratory valve sets with membranes sticking to valve body, not detectable during pre-operative test, which will result in "exhalation obstructed " alarm, which may result in inadequate ventilation, oxygen desaturation. Advising: Prior to use, test lung action. If alarm occurs, expiratory valve set removal t… — Hamilton Medical AG · Class I · Ongoing · 27,270 pcs
Potential sterile breach of the pouches in which devices are packaged. — Boston Scientific Corporation · Class II · Ongoing · 81,543 units
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier. — Bard Access Systems, Inc. · Class II · Ongoing · 66
In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and initiate motion using the in-room control pendant, the collimator may release and fall from the housing. — Accuray Incorporated · Class II · Ongoing · 292 units
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss. — Medline Industries, LP · Class II · Ongoing · 9,272 kits
The Adapter for Head Positioning accessory may become loose during patient positioning and unintentionally move when used in conjunction with the side rails of the Upper Back Section H V U component on Baxter operating tables. — Baxter Healthcare Corporation · Class II · Ongoing · 13 units
External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The primary failure mode is pump under-delivery due to loss of insulin to an external leak. If insulin is not delivered properly, users may experience high blood glucose levels due t… — Insulet Corporation · Class I · Ongoing · 1,790,784 units
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site. — Medline Industries, LP · Class II · Ongoing · 420 kits
Potential sterile breach of the pouches in which devices are packaged. — Boston Scientific Corporation · Class II · Ongoing · 81,543 units
Potential sterile breach of the pouches in which devices are packaged. — Boston Scientific Corporation · Class II · Ongoing · 81,543 units
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site. — Medline Industries, LP · Class II · Ongoing · 270 kits
Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit. — Windstone Medical Packaging, Inc. · Class I · Ongoing · 45 units
Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find another readily available device. — Zimmer Surgical Inc · Class II · Ongoing · 14360
Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits. — Siemens Medical Solutions USA, Inc · Class II · Ongoing · 30 units
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. — DEPUY (IRELAND) · Class II · Ongoing · 160 units
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier. — Bard Access Systems, Inc. · Class II · Ongoing · 9,500
Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit. — Windstone Medical Packaging, Inc. · Class I · Ongoing · 200 units
There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after ad… — Baxter Healthcare Corporation · Class I · Ongoing · 13881 units
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier. — Bard Access Systems, Inc. · Class II · Ongoing · 120
Potential sterile breach of the pouches in which devices are packaged. — Boston Scientific Corporation · Class II · Ongoing · 81,543 units
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier. — Bard Access Systems, Inc. · Class II · Ongoing · 2,844
Potential sterile breach of the pouches in which devices are packaged. — Boston Scientific Corporation · Class II · Ongoing · 81,543 units