All Recalls

Lack of Assurance of Sterility; product has the potential to leak.

Lack of Assurance of Sterility; product has the potential to leak.

Lack of Assurance of Sterility; product has the potential to leak.

Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.

Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.

Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a quantity that exceeds allowable limits.

The label of the CADD Blue-Striped Administrative Set is missing the expiration date, which is considered a regulatory compliance issue for Canada.

The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been associated to a patient death due to the failure of the device to initiate therapy.

Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a quantity that exceeds allowable limits.

The investigation demonstrated a high rate of very major errors (resistant isolates calling susceptible) with the VITEK¿ 2 AST-GN colistin (cs01n) compared to agar dilution (the reference method used for cs01n development) and compared to broth-microdilution (recommended method by EUCAST/CLSI).

Medtronic has become aware that the VCLAS 15MM TIP cap, also referred to as Tuohy Borst Adapter (TBA), may not be capable of creating a seal around the optical fiber to ensure adequate saline flow through the cooling system. When the TBA is unable to seal around the optical fiber, low retention force to the optical fiber may occur, causing saline to leak out of the TBA.

Outer label of some units of product number/lot number 8482, Lot 16LFS235 and product number/lot number 9414, Lot 16LUS317 do not match the drape packaged inside.

An issue was discovered with the Pacific Hemostasis Fibrinogen Degradation Products (FDP) kit, list number 100650, lot 948546 and FDP Latex Reagent, list 100651, lot 890199. While the kit performs accurately at FDP concentrations greater than 20 ¿g/ml, there is an observed reduction in sensitivity when FDP levels are less than 20 ¿g/ml. This reduction in sensitivity has been tied to FDP Latex Reagent lot 890199 and may result in false negatives.

Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.

Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a quantity that exceeds allowable limits.

Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a quantity that exceeds allowable limits.

Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.

Outer label of some units of product number/lot number 8482, Lot 16LFS235 and product number/lot number 9414, Lot 16LUS317 do not match the drape packaged inside.

The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been associated to a patient death due to the failure of the device to initiate therapy.

Firm received a complaint that a customer who ordered an ADVANTA V12 7mm x 22mm x 120cm received an ADVANTA v12 7 mm x 38 mm x 80 cm, due to the manifold (catheter hub) was printed as 7mm x 38 mm x 80 cm. The complaint was the result of incorrect dimensional information (7mm x 38mm x 80cm) printed on the manifiold (catheter hub). The complaint device physical dimensions matched the dimensional information displayed on the outer packaging and the device inner pouch. This was the only complaint received for this non-conformance.