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Infusion Pumps

HEMASHIELD PLATINUM Woven Double Velour Vascular Graft01 Branch, Product Code: M00202175834P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.

Maquet Cardiovascular

Class I - Dangerous

Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts

Apr 7, 2020 Infusion Pumps Nationwide View Details →

HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-1 Branch, Product Code: M00202175832P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.

Maquet Cardiovascular

Class I - Dangerous

Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts

Apr 7, 2020 Infusion Pumps Nationwide View Details →

BodyGuard Microset For Use with the BodyGuard Infusion Pump *** Tubing: 110 in. (280 cm) - Blue Stripe - Product Usage: The system is intended for patients who require maintenance medications, PCA therapy, parenteral nutritional fluids, and general IV fluid therapy in hospital and home care environments.

CME America

Class I - Dangerous

The filter installed onto the tube set may have the incorrect pore size.

Jan 14, 2020 Infusion Pumps Nationwide View Details →

Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A3 C17/5 - ceramic for dental use, intended for IPS e.max ZirCAD presintered yttrium oxide-stabilized zirconium oxide blocks for the CAD/ CAM technology Product Number: 686195

Ivoclar Vivadent AG

Class I - Dangerous

Restorations crack during the sintering process.

Apr 13, 2020 Infusion Pumps Nationwide View Details →

HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175732P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.

Maquet Cardiovascular

Class I - Dangerous

Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts

Apr 7, 2020 Infusion Pumps Nationwide View Details →

HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175924P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.

Maquet Cardiovascular

Class I - Dangerous

Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts

Apr 7, 2020 Infusion Pumps Nationwide View Details →

HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Thoracoabdominal, Product Code: M00202175428T0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.

Maquet Cardiovascular

Class I - Dangerous

Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts

Apr 7, 2020 Infusion Pumps Nationwide View Details →

ARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus.

Abbott Laboratories

Class I - Dangerous

Error in the renewal documentation process for license in Mexico. All in date ARCHITECT C Peptide Reagents, Calibrators and Controls are being recalled until a new license is obtained.

Apr 1, 2020 Infusion Pumps View Details →

Varian Multileaf Collimator [MLC]; Millenium Multileaf Collimator [52, 80, 120 leaf]; High Definition 120 Multileaf Collimator Model Number(s): product code: H54 and H56; MLC software version 8.5 - Product Usage: is intended to assist the clinician in the delivery of external beam radiation to defined target volumes during radiosurgery and radiotherapy while sparing surrounding normal tissue and critical organs from excess radiation.

Varian Medical Systems

Class I - Dangerous

After a recent upgrade to the collimator software version 8.5, the firm became aware that the multi-leaf collimator leaves did not move during an arc treatment. The issue is related to a transient carriage primary- secondary interlock due to carriage fault on the MLC that immediately preceded the initiation of the arc treatment. The issue will occur only with MLC software version 8.5 and only affects conformal arc treatments, including VMAT and RapidArc. There have been no reports of adverse health consequences due to this issue.

Aug 12, 2019 Infusion Pumps Nationwide View Details →

HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 4 Branch, Product Code: M00202175928P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.

Maquet Cardiovascular

Class I - Dangerous

Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts

Apr 7, 2020 Infusion Pumps Nationwide View Details →

ARCHITECT C Peptide Reagent - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus.

Abbott Laboratories

Class I - Dangerous

Error in the renewal documentation process for license in Mexico. All in date ARCHITECT C Peptide Reagents, Calibrators and Controls are being recalled until a new license is obtained.

Apr 1, 2020 Infusion Pumps View Details →

HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 4 Branch, Product Code: M00202175734P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.

Maquet Cardiovascular

Class I - Dangerous

Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts

Apr 7, 2020 Infusion Pumps Nationwide View Details →

HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175828P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.

Maquet Cardiovascular

Class I - Dangerous

Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts

Apr 7, 2020 Infusion Pumps Nationwide View Details →

HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175926P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.

Maquet Cardiovascular

Class I - Dangerous

Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts

Apr 7, 2020 Infusion Pumps Nationwide View Details →

Hemashield Gold Knitted Microvel Double Velour Vascular Graft-Axillo-bifemoral, Product Code: M002020955880 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease

Maquet Cardiovascular

Class I - Dangerous

Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts

Apr 7, 2020 Infusion Pumps Nationwide View Details →

HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Thoracoabdominal, Product Code: M00202175426T0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.

Maquet Cardiovascular

Class I - Dangerous

Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts

Apr 7, 2020 Infusion Pumps Nationwide View Details →

HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175824P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.

Maquet Cardiovascular

Class I - Dangerous

Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts

Apr 7, 2020 Infusion Pumps Nationwide View Details →

HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175922P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.

Maquet Cardiovascular

Class I - Dangerous

Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts

Apr 7, 2020 Infusion Pumps Nationwide View Details →

ARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus.

Abbott Laboratories

Class I - Dangerous

Error in the renewal documentation process for license in Mexico. All in date ARCHITECT C Peptide Reagents, Calibrators and Controls are being recalled until a new license is obtained.

Apr 1, 2020 Infusion Pumps View Details →

HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Angled 4 Branch, Product Code: M00202175728AP0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.

Maquet Cardiovascular

Class I - Dangerous

Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts

Apr 7, 2020 Infusion Pumps Nationwide View Details →

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