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Showing 5801–5820 of 11714 results

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Phantom TTC Nail (Paragon 28) – pre-sterilization distribution (2023)

Medical devices distributed, prior to sterilization

FDADec 21, 2023CA• Paragon 28, Inc. 14445 Grasslands Dr Englewood CO 80112-7062

Phantom TTC Nail (Paragon 28) – pre-sterilization distribution (2023)

Medical devices distributed, prior to sterilization

FDADec 21, 2023CA• Paragon 28, Inc. 14445 Grasslands Dr Englewood CO 80112-7062

Surgilon Sutures (Unknown) – gamma radiation strength issue (2023)

Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the sutures over time, which could result in harms such as wound dehiscence and hemorrhage/blood loss/ bleeding at a critical level.

High

FDADec 21, 2023Nationwide

Henry Schein Masks (AMD Medicom) – production equipment problem (2023)

Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.

FDADec 21, 2023Nationwide• AMD Medicom Inc. 2555 Ch de L'Aviation Montreal Canada

Medline Blood Culture Tray (Medline) – kit quality issue (2023)

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. This recall is due to kits built using a Bactec component lot and expiration date that were not reflected on the kit insert. There is a risk of using an expired component if the user does not check the Bactec inside the kit for its expiration date.

FDADec 21, 2023Nationwide• MEDLINE INDUSTRIES, LP Northfield

Medline Blood Culture Kit (Medline) – kit quality issue (2023)

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. This recall is due to kits built using a Bactec component lot and expiration date that were not reflected on the kit insert. There is a risk of using an expired component if the user does not check the Bactec inside the kit for its expiration date.

FDADec 21, 2023Nationwide• MEDLINE INDUSTRIES, LP Northfield

Medline Blood Culture Kit (Medline) – kit quality issue (2023)

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. This recall is due to kits built using a Bactec component lot and expiration date that were not reflected on the kit insert. There is a risk of using an expired component if the user does not check the Bactec inside the kit for its expiration date.

FDADec 21, 2023Nationwide• MEDLINE INDUSTRIES, LP Northfield

Cardinal Health Suction Canister (Cardinal Health) – suction loss risk (2023)

The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience loss of suction on low or low intermittent suction settings, due to a misalignment of the liner with the outer hard canister.

FDADec 21, 2023Nationwide• Cardinal Health 200, LLC

Sofsilk Sutures (Unknown) – gamma radiation strength issue (2023)

Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the sutures over time, which could result in harms such as wound dehiscence and hemorrhage/blood loss/ bleeding at a critical level.

FDADec 21, 2023Nationwide

Cardinal Health Suction Canister (Cardinal Health) – suction loss risk (2023)

The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience loss of suction on low or low intermittent suction settings, due to a misalignment of the liner with the outer hard canister.

FDADec 21, 2023Nationwide• Cardinal Health 200, LLC

Rebstock Holding Rod (Medagent) – uncontrolled movement risk (2023)

Holding arm could move (twist) uncontrollably in the front area. This could lead to a serious deterioration of patient's safety if the movement is transferred to the spatula, which is attached to the holding arm.

FDADec 21, 2023TX• Medagent Inc

Cardinal Health Suction Canister (Cardinal Health) – suction loss risk (2023)

The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience loss of suction on low or low intermittent suction settings, due to a misalignment of the liner with the outer hard canister.

FDADec 21, 2023Nationwide• Cardinal Health 200, LLC

Patterson Procedure Masks (AMD Medicom) – production equipment problem (2023)

Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.

FDADec 21, 2023Nationwide• AMD Medicom Inc. 2555 Ch de L'Aviation Montreal Canada

Valiant PhD (Ivoclar Vivadent) – performance inconsistency (2023)

Affected product may not perform as expected; the amalgam powder may not triturate correctly and the physical properties (i.e. strength, compression, working time, etc.) will be adversely affected.

FDADec 21, 2023Nationwide• Ivoclar Vivadent, Inc.

Magnesium Citrate Laxative (Walgreens) – Bacterial Contamination (2023)

MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.

Class IIModerate

FDADec 21, 2023Nationwide• Pharma Nobis LLC

Good Neighbor Magnesium Citrate (Pharma Nobis) – Bacterial Contamination (2023)

MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.

Class IIModerate

FDADec 21, 2023Nationwide• Pharma Nobis LLC

Bleomycin Injection (Pfizer) – Glass Particulate Matter (2023)

Presence of particulate matter: glass

FDADec 21, 2023Nationwide• PFIZER

Freskaro Magnesium Citrate Laxative Chewable (Pharma Nobis) – Bacterial Contamination (2023)

MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.

Class IIModerate

FDADec 21, 2023Nationwide• Pharma Nobis LLC

Sodium Bicarbonate Injection (Pfizer) – Glass Particulate Matter (2023)

Presence of Particulate Matter; identified as glass

FDADec 21, 2023Nationwide• Pfizer Inc.

Atropine Sulfate Injection (Pfizer) – Glass Particulate Matter (2023)

Presence of Particulate Matter; identified as glass

FDADec 21, 2023Nationwide• Pfizer Inc.

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