34 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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ARCHITECT CA 19-9XR Reagent Kit; ARCHITECT CA 19-9 Reagent Kit, list 291-20 (4 x 100 tests), 2K91-25 and 2K91-27 (1 x 100 tests); Product Usage: The ARCHITECT CA 19-9XR assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of 1116-NS-19-9 reactive determinants in human serum or plasma on the ARCHITECT i System. The ARCHITECT CA-19-9XR assay is to be used as an aid in the management of pancreatic cancer patients in conjunction with other clinical methods.
FDA Recall
Terminated
·Abbott Laboratories·Product code NIG·May 30, 2012
ARCHITECT CA 19-9XR Reagent Kit; ARCHITECT CA 19-9 Reagent Kit, list 291-20 (4 x 100 tests), 2K91-25 and 2K91-27 (1 x 100 tests); Product Usage: The ARCHITECT CA 19-9XR assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of 1116-NS-19-9 reactive determinants in human serum or plasma on the ARCHITECT i System. The ARCHITECT CA-19-9XR assay is to be used as an aid in the management of pancreatic cancer patients in conjunction with other clinical methods.
FDA Enforcement
Class II
·Terminated·Abbott Laboratories·July 4, 2012
Euflexxa (1% sodium hyaluronate). Pre-filled syringe, Rx only, 3 syringes per carton; Manufactured by Ferring Pharmaceuticals In, Parsippany, NJ 07054; Manufactured by Bio-Technology General (Israel Ltd. Be er Tuvia, Kiryat Malachi 83104 Israel. Indicated for the treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics.
FDA Recall
Terminated
·Ferring Pharmaceuticals Inc·Product code MOZ·April 16, 2010
LHB, Type I First Aid Kit Perishable, Non-Aspirin 4/pg, Aspirin 4/pg and Povidone Iodine, antiseptic towelette. Kit Number: 2113110. First Aid Kit.
FDA Recall
Terminated
·Lighthouse For The Blind·Product code LRR·March 22, 2013
LHB, Antiseptic Kit, Povidone Swab, Gauze Pads, and non-stick pads. Kit Number: 2113305. First Aid Kit.
FDA Recall
Terminated
·Lighthouse For The Blind·Product code LRR·March 22, 2013
LHB, First Aid Type I Individual Kit, NSN: 6545-00-656-1092, antiseptics, Kit number: 2114002. First Aid Kit.
FDA Recall
Terminated
·Lighthouse For The Blind·Product code LRR·March 22, 2013
LHB, Perishable Items Pack Type I , Kit Number: 2114002-100. First Aid Kit.
FDA Recall
Terminated
·Lighthouse For The Blind·Product code LRR·March 22, 2013
LHB, First Aid Type IV Belt Type, NSN #6545-01-010-7754. Kit number: 114016. First Aid Kit.
FDA Recall
Terminated
·Lighthouse For The Blind·Product code LRR·March 22, 2013
LHB, Perishable Items Pack Type IV. Kit number: 2114016-100. First Aid Kit.
FDA Recall
Terminated
·Lighthouse For The Blind·Product code LRR·March 22, 2013
LHB, Perishable Item Pack Type III. Kit number: 2114011-100. First Aid Kit.
FDA Recall
Terminated
·Lighthouse For The Blind·Product code LRR·March 22, 2013
LHB, First Aid Type III, NSN # 6545-00-656-1094, Kit number: 2114011. First Aid Kit.
FDA Recall
Terminated
·Lighthouse For The Blind·Product code LRR·March 22, 2013
Plasma Pump Model PP-04a Used with Asahi Plasmaflo Plasma Separators and plasma exchange tubesets to perform therapeutic plasma exchange.
FDA Recall
Terminated
·Apheresis Technologies, Inc.·Product code FIR·July 9, 2012
Owner Manual Modifications for PlasmaPro Plasma Pump Model PP-05. Apheresis Technologies, Inc. Palm Harbor, FL. - No labeling or Packaging. Used with Asahi Plasma Separators to perform therapeutic plasma exchange.
FDA Recall
Terminated
·Apheresis Technologies, Inc.·Product code FIR·April 1, 2009
GelPOINT Path Transanal Procedural Pack with Epix Electrosurgical L-Hook with Smoke Evacuation, 4x5.5cm and 5mm x 42cm REF TA211 Product Usage: The GelPOINT Path Transanal Access Platform is indicated for multiple instrument or camera access through the anus to perform various diagnostic and/or therapeutic procedures by using additional instruments.
FDA Recall
Terminated
·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code FER·December 12, 2018
PlasmaPrO" Plasma Pump Model PP-05 Product Usage: The PlasmaPro Plasma Pump is a pump to be used with Asahi Plasma Separators to perform therapeutic plasma exchange.
FDA Recall
Terminated
·Apheresis Technologies, Inc.·Product code FIR·November 29, 2010
SS 4.5MM DIAMOND TIP TROCAR WITH LARGE GLOVES Catalog Number:B1559
FDA Recall
Terminated
·Busse Hospital Disposables, Inc.·Product code FBR·February 22, 2022
LHB, First Aid Type I Individual Kit, NSN: 6545-00-656-1092, antiseptics, Kit number: 2114002. First Aid Kit.
FDA Enforcement
Class III
·Terminated·Lighthouse For The Blind·April 17, 2013
LHB, Perishable Items Pack Type IV. Kit number: 2114016-100. First Aid Kit.
FDA Enforcement
Class III
·Terminated·Lighthouse For The Blind·April 17, 2013
LHB, First Aid Type IV Belt Type, NSN #6545-01-010-7754. Kit number: 114016. First Aid Kit.
FDA Enforcement
Class III
·Terminated·Lighthouse For The Blind·April 17, 2013
LHB, Antiseptic Kit, Povidone Swab, Gauze Pads, and non-stick pads. Kit Number: 2113305. First Aid Kit.
FDA Enforcement
Class III
·Terminated·Lighthouse For The Blind·April 17, 2013