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Showing 1581–1600 of 1734 results

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Vista Brite Tip (Cordis) – catheter length error (2025)

Catheter manufactured at the incorrect length.

FDAFeb 7, 2025WA• Cordis US Corp

Bodor I Series Laser (Jinan Bodor) – federal standard (2025)

The Bodor i Series products fail to meet certain applicable Federal standards, 21 CFR 1040.10(f)(1) and 21 CFR 1040.10(f)(2).

FDAFeb 7, 2025Nationwide• Jinan Bodor Cnc Machine Co Ltd NO.1299, XINLUO AVE HI-TECH ZONE Jinan China

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

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

Spine Lumbar 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

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

Thoracic 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

Uro Robotic 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

Total Hip 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

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.

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

Labor & Delivery 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

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

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

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

DxI 9000 Analyzer (Beckman Coulter) – interface board issue (2025)

Beckman Coulter identified that an issue for DxI 9000 tip stocker interface (TSI) and reagent storage interface (RSI) boards with the firmware version 1.1.0.0 can cause sub-system communication failures. This failure could result in a delay in reporting patient results.

FDAFeb 6, 2025Nationwide• Beckman Coulter, Inc.

General Laparoscopic 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

Born on Arrival Kit (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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