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Showing 4961–4980 of 8389 results

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Slick Set Uncuffed Tube (TELEFLEX) – Connector Disconnection (2023)

Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

FDAMay 25, 2023Nationwide• TELEFLEX LLC

Pilling LOWSLEY PROSTATIC TRACTOR CVD, REF 243200; retractor (TELEFLEX LLC) – there are incomplete pre-cleaning ins... (2023)

There are incomplete pre-cleaning instructions within the Instructions for Use (IFU).

FDAMay 25, 2023Nationwide• TELEFLEX LLC

Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF... (TELEFLEX LLC) – reports of disconnection of the 15mm ... (2023)

Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

High

FDAMay 25, 2023Nationwide• TELEFLEX LLC

EliA GBM Wells, Material Number 14551401, for Phadia 250,... (Phadia Ab Rapsgatan Plant Rapsgatan 7 Uppsala Sweden) – complaints that specific samples prod... (2023)

Complaints that specific samples produced false positive EliA GBM results. A positive signal was present when these samples were tested for coating-solution reactivity using EliA wells without antigen.

FDAMay 24, 2023Nationwide• Phadia Ab Rapsgatan Plant Rapsgatan 7 Uppsala Sweden

RET Proximal Probe. Used in Fluorescence in situ hybridiz... (Cytocell Ltd. 418 Cambridge Science Park, Milton Road Oxford Gene Technology Cambridge United Kingdom) – dnas used during the manufacture of t... (2023)

DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing.

FDAMay 24, 2023Nationwide• Cytocell Ltd. 418 Cambridge Science Park, Milton Road Oxford Gene Technology Cambridge United Kingdom

Power-PRO 2- A powered ambulance cot that consists of a p... (Stryker Medical Division of Stryker Corporation) – base leg assembly may bend and result... (2023)

Base leg assembly may bend and result in difficulty engaging/disengaging from fastener, difficulty loading/unloading from ambulance, difficulty raising or lowering the cot, cot tip, or erratic or unintended motion.

FDAMay 24, 2023Nationwide• Stryker Medical Division of Stryker Corporation

NeuMoDx Cartridge-used for extraction, purification, ampl... (NeuMoDx Molecular Inc) – top label on some of the neumodx cart... (2023)

Top label on some of the NeuMoDx cartridges within these lots may have been incorrectly applied during the manufacturing process, resulting in encroachment into the PCR region. The misplaced label may interfere with the module s optics performance, thereby increasing the risk for false positive results

FDAMay 24, 2023Nationwide• NeuMoDx Molecular Inc

RET Distal Probe. Used in Fluorescence in situ hybridizat... (Cytocell Ltd. 418 Cambridge Science Park, Milton Road Oxford Gene Technology Cambridge United Kingdom) – dnas used during the manufacture of t... (2023)

DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing.

FDAMay 24, 2023Nationwide• Cytocell Ltd. 418 Cambridge Science Park, Milton Road Oxford Gene Technology Cambridge United Kingdom

SurgiMend PRS; Collagen Matrix for Soft Tissue Reconstruc... (TEI Biosciences, Inc.) – possible out of specification endotox... (2023)

Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.

FDAMay 23, 2023Nationwide• TEI Biosciences, Inc.

SurgiMend 4.0; Collagen Matrix for Soft Tissue Reconstruc... (TEI Biosciences, Inc.) – possible out of specification endotox... (2023)

Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.

FDAMay 23, 2023Nationwide• TEI Biosciences, Inc.

SurgiMend 1.0; Collagen Matrix for Soft Tissue Reconstruc... (TEI Biosciences, Inc.) – possible out of specification endotox... (2023)

Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.

FDAMay 23, 2023Nationwide• TEI Biosciences, Inc.

SurgiMend MP; Collagen Matrix for Soft Tissue Reconstruct... (TEI Biosciences, Inc.) – possible out of specification endotox... (2023)

Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.

FDAMay 23, 2023Nationwide• TEI Biosciences, Inc.

PriMatrix Ag Fenestrated; Dermal Repair Scaffold; Rx Only... (TEI Biosciences, Inc.) – possible out of specification endotox... (2023)

Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.

FDAMay 23, 2023Nationwide• TEI Biosciences, Inc.

SurgiMend 2.0; Collagen Matrix for Soft Tissue Reconstruc... (TEI Biosciences, Inc.) – possible out of specification endotox... (2023)

Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.

FDAMay 23, 2023Nationwide• TEI Biosciences, Inc.

BencoDental iris 5% NaF varnish, WHITE MINT ITEM # 4323-6... (Young Dental Manufacturing I, LLC) – the iris 5% fluoride varnish white mi... (2023)

The Iris 5% Fluoride Varnish White Mint package lot 207540 may contain units of 5% Fluoride Varnish Bubblegum.

FDAMay 23, 2023FL, NV, PA• Young Dental Manufacturing I, LLC

SurgiMend 3.0; Collagen Matrix for Soft Tissue Reconstruc... (TEI Biosciences, Inc.) – possible out of specification endotox... (2023)

Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.

FDAMay 23, 2023Nationwide• TEI Biosciences, Inc.

Revize-X; Collagen Matrix for Soft Tissue Reconstruction;... (TEI Biosciences, Inc.) – possible out of specification endotox... (2023)

Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.

FDAMay 23, 2023Nationwide• TEI Biosciences, Inc.

wDR 2.2 Mobile Digital Diagnostic X-Ray System (SEDECAL SA PELAYA, 9 POL. POL. IND. RIO DE JANEIRO Algete Spain) – there is a software login in issue th... (2023)

There is a software login in issue that may prevent the user from logging in.

FDAMay 23, 2023Nationwide• SEDECAL SA PELAYA, 9 POL. POL. IND. RIO DE JANEIRO Algete Spain

PriMatrix Fenestrated; Dermal Repair Scaffold; Rx Only; S... (TEI Biosciences, Inc.) – possible out of specification endotox... (2023)

Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.

FDAMay 23, 2023Nationwide• TEI Biosciences, Inc.

PriMatrix Meshed; Dermal Repair Scaffold; Rx Only; Sizes ... (TEI Biosciences, Inc.) – possible out of specification endotox... (2023)

Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.

FDAMay 23, 2023Nationwide• TEI Biosciences, Inc.

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