Physio-Control, Inc. recalls STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20 STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP15 Defibrillation is indicated…
Due to customer complaints and out of box failures, the firm is conducting a voluntary recall as a result of product failures (cracks and over-molding separation of the sterilizable internal defibrillation paddles.
Read the official notice →- Date
- 2024-10-30
- Country
- United States
- Brand
- Physio-Control
- Product
- STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20 STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP15 Defibrillation is indicated…
- Classification
- Class II
- Units
- Worldwide - U.S. Nationwide distribution including in the states of AL, AR,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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FDA · DevicePhysio-Control, Inc.U.S. Nationwide distribution including in the states of CA, CO, CT, FL, GA,…Official notice →- 2025-02-12
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Product shipped with incorrect IFU. IFU does not include proper cleaning/disinfection instructions
FDA · DevicePhysio-Control, Inc.U.S. Nationwide distribution in the states of CA, FL, GA, IA, IN, KY, MD, MI,…Official notice →- 2024-11-06
US
Physio-Control, Inc. recalls LIFEPAK 15 (LP15) Model/Catalog Numbers: o 97577-000101 o 99577-000046 o 99577-000055 o 99577-000061 o 99577-000076 o 99577-001250 o…
Due to an out of tolerance tool being used on monitor/defibrillator systems.
- 2023-12-27
US
Physio-Control, Inc. recalls AC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator, REF: 11140-000098
AC Power Adapter (ACPA) may not charge the monitor/defibrillator batteries and may not allow the monitor/defibrillator to power on while plugged into the ACPA.
FDA · DevicePhysio-Control, Inc.US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO,…Official notice →- 2023-11-22
US
Physio-Control, Inc. recalls LIFEPAK 15, REF: 99577-000046, Part Number V15-2-000051
Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
FDA · DevicePhysio-Control, Inc.US Nationwide distribution in the states of AZ, CA, NC, NJ, NY.Official notice →- 2022-03-16
US
Physio-Control, Inc. recalls HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillator, used with Pad-Pak
Semi-automatic defibrillators shipped out by Stryker without battery and electrode packs.
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US
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Uncertainty in the seal integrity of the sterile packaging.
US
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION recalls Trinias unity, Digital Angiography System with Catheterization Table, Model: KS-100 This system consists of the…
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