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Showing 3341–3360 of 68218 results

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Pan de Sal Spanish Rolls (Jesse's Bakery) – Undeclared Milk (2025)

Undeclared Milk

Undeclared Milk.

FDAFeb 7, 2025HI, IN• Jesse's Bakery, Inc.

Las Ollas Botana Mix (Kedake) – Undeclared Allergens (2025)

Undeclared Allergen

Undeclared Sesame, Soy, Wheat, Yellow No. 5, Yellow No. 6, and Red No. 6.

FDAFeb 7, 2025TX• Kedake Inc

C-Section PPS Pack (American Contract) – sterilization uncertainty (2025)

ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.

Moderate

FDAFeb 6, 2025Nationwide• American Contract Systems Inc

Cysto Pack (American Contract) – sterilization uncertainty (2025)

ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.

FDAFeb 6, 2025Nationwide• American Contract Systems Inc

Ear Pack (American Contract) – sterilization uncertainty (2025)

ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.

FDAFeb 6, 2025Nationwide• American Contract Systems Inc

CV Basic Pump Pack (American Contract) – sterilization uncertainty (2025)

ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.

FDAFeb 6, 2025Nationwide• American Contract Systems Inc

Open Heart Adult Pack (American Contract) – sterilization uncertainty (2025)

ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.

FDAFeb 6, 2025Nationwide• American Contract Systems Inc

Central Line PICC (American Contract) – sterilization uncertainty (2025)

ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.

FDAFeb 6, 2025Nationwide• American Contract Systems Inc

C-Section Pack (American Contract) – sterilization uncertainty (2025)

ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.

FDAFeb 6, 2025Nationwide• American Contract Systems Inc

Diagnostic Neuro IR Tray (American Contract) – sterilization uncertainty (2025)

ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.

FDAFeb 6, 2025Nationwide• American Contract Systems Inc

AV Fistula (American Contract) – sterilization uncertainty (2025)

ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.

FDAFeb 6, 2025Nationwide• American Contract Systems Inc

Major DIEP Pack (American Contract) – sterilization uncertainty (2025)

ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.

FDAFeb 6, 2025Nationwide• American Contract Systems Inc

Laparoscopy Pack (American Contract) – sterilization uncertainty (2025)

ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.

FDAFeb 6, 2025Nationwide• American Contract Systems Inc

Major Vascular Pack (American Contract) – sterilization uncertainty (2025)

ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.

FDAFeb 6, 2025Nationwide• American Contract Systems Inc

Open Heart A Pack (American Contract) – sterilization uncertainty (2025)

ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.

FDAFeb 6, 2025Nationwide• American Contract Systems Inc

Laparoscopy Pack (American Contract) – sterilization uncertainty (2025)

ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.

FDAFeb 6, 2025Nationwide• American Contract Systems Inc

ReNewal Livewire Catheter (Medline) – endotoxin levels (2025)

Devices may have higher than expected amounts of bacterial endotoxin.

FDAFeb 6, 2025Nationwide• MEDLINE INDUSTRIES, LP Northfield

Neuro IR Tray (American Contract) – sterilization uncertainty (2025)

ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.

FDAFeb 6, 2025Nationwide• American Contract Systems Inc

BD Pyxis (CareFusion) – server sync timeout (2025)

Sync timeout may occur between the server and automated dispensing device, due to a server software error which may occur if syncing a large amount of data that takes excessive time, which may cause the dispensing devices to become disconnected from the ES server; dispensing devices will not receive updated information, which may lead to incorrect therapy, and delay in accessing medication.

FDAFeb 6, 2025Nationwide• CareFusion 303, Inc.

Vein Tray (American Contract) – sterilization uncertainty (2025)

ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.

FDAFeb 6, 2025Nationwide• American Contract Systems Inc

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