🔍 RecallPedia

STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20 STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP15 Defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Synchronized cardioversion is indicated for the treatment of atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, supraventricular tachycardia, and in relatively stable patients, ventricular tachycardia.

Class I - Dangerous
🏥 Medical Devices Recalled: August 9, 2024 Physio-Control Infusion Pumps Nationwide

What Should You Do?

  1. Check if you have this product:
    LP20 Model/Catalog Number: 11131-000040 UDI-DI codes: 00883873863558 Part Number: 3317813-001 Serial Numbers: 101648901 86557878 87141562 88458193 88482392 93989670 Part Number: 3317813-005 Serial Number: 107741863 Model/Catalog Number: 11131-000041 UDI-DI code: 00883873863534 Part Number: 3317813-002 Serial Numbers: 86287034 86949592 90445090 91624045 93441890 Part Number: 3317813-006 Serial Number: 107556559 Model/Catalog Number: 11131-000042 UDI-DI code: 00883873863527 Part Number: 3317813-003 Serial Numbers: 100198569 100759224 101002312 101042672 101383090 84830138 84881382 84915416 86240215 86260453 86557878 86949593 87794908 90445091 91380577 92185462 96496375 96496376 96496377 97059498 Part Number: 3317813-007 Serial Numbers: 105817428 106332158 107556560 Model/Catalog Number: 11131-000043 UDI-DI code: 00883873863510 Part Number: 3317813-004 Serial Numbers: 101506304 86949594 90445092 LP15 Model/Catalog Number: 11131-000044 UDI-DI code: 00883873863503 Part Number: 3317814-001 Serial Numbers: 90445093 93441892 98719352 98719353 99649024 99649025 Part Number: 3317814-005 Serial Number: 107124577 Model/Catalog Number: 11131-000045 UDI-DI code: 00883873863497 Part Number: 3317814-003 Serial Numbers: 101888461 101888462 101888463 102107169 103669336 103669337 104125087 104129892 104440600 86280420 90445095 92556517 92871913 95836040 97111384 98719364 98719365 98813631 99692098 Part Number: 3317814-007 Serial Numbers: 106555464 106721716 106917875 106968460 107445069 107741891 Model/Catalog Number: 11131-000046 UDI-DI code: 00883873863480 Part Number: 3317814-004 Serial Numbers: 90445096 98719376 98813643 98990261 99692108 Part Number: 3317814-008 Serial Numbers: 107124605 Model/Catalog Number: 11131-000047 UDI-DI code: 00883873863213 Part Number: 3317814-002 Serial Numbers: 84830141 90445094 91515844 92556516 92871911 93441893 98719358 98719359 99692092 Part Number: 3317814-006 Serial Numbers: 107078533 107445059
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Physio-Control, Inc.
Reason for Recall:
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20 STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP15 Defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Synchronized cardioversion is indicated for the treatment of atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, supraventricular tachycardia, and in relatively stable patients, ventricular tachycardia.

Product Codes/Lot Numbers:

LP20 Model/Catalog Number: 11131-000040 UDI-DI codes: 00883873863558 Part Number: 3317813-001 Serial Numbers: 101648901 86557878 87141562 88458193 88482392 93989670 Part Number: 3317813-005 Serial Number: 107741863 Model/Catalog Number: 11131-000041 UDI-DI code: 00883873863534 Part Number: 3317813-002 Serial Numbers: 86287034 86949592 90445090 91624045 93441890 Part Number: 3317813-006 Serial Number: 107556559 Model/Catalog Number: 11131-000042 UDI-DI code: 00883873863527 Part Number: 3317813-003 Serial Numbers: 100198569 100759224 101002312 101042672 101383090 84830138 84881382 84915416 86240215 86260453 86557878 86949593 87794908 90445091 91380577 92185462 96496375 96496376 96496377 97059498 Part Number: 3317813-007 Serial Numbers: 105817428 106332158 107556560 Model/Catalog Number: 11131-000043 UDI-DI code: 00883873863510 Part Number: 3317813-004 Serial Numbers: 101506304 86949594 90445092 LP15 Model/Catalog Number: 11131-000044 UDI-DI code: 00883873863503 Part Number: 3317814-001 Serial Numbers: 90445093 93441892 98719352 98719353 99649024 99649025 Part Number: 3317814-005 Serial Number: 107124577 Model/Catalog Number: 11131-000045 UDI-DI code: 00883873863497 Part Number: 3317814-003 Serial Numbers: 101888461 101888462 101888463 102107169 103669336 103669337 104125087 104129892 104440600 86280420 90445095 92556517 92871913 95836040 97111384 98719364 98719365 98813631 99692098 Part Number: 3317814-007 Serial Numbers: 106555464 106721716 106917875 106968460 107445069 107741891 Model/Catalog Number: 11131-000046 UDI-DI code: 00883873863480 Part Number: 3317814-004 Serial Numbers: 90445096 98719376 98813643 98990261 99692108 Part Number: 3317814-008 Serial Numbers: 107124605 Model/Catalog Number: 11131-000047 UDI-DI code: 00883873863213 Part Number: 3317814-002 Serial Numbers: 84830141 90445094 91515844 92556516 92871911 93441893 98719358 98719359 99692092 Part Number: 3317814-006 Serial Numbers: 107078533 107445059

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0142-2025

Related Recalls

LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434 883873785911 LIFEPAK CR2: The LIFEPAK CR2 defibrillator is indicated for use on patients 1 year of age or older in cardiopulmonary arrest. The patient must be unresponsive (unconscious), not breathing normally, and showing no signs of circulation (for example, no pulse, no coughing, or no movement). The cprCOACHTM Feedback Technology in the LIFEPAK CR2 defibrillator is indicated for use on cardiopulmonary arrest patients and provides CPR guidance in accordance with the AHA Guidelines for patients 1 year of age or older. The LIFEPAK CR2 defibrillator is intended for use by personnel who have been trained in its operation. Users should have received training in basic life support/AED, advanced life support, or a physician-authorized emergency medical response training program.

Physio-Control

Class I - Dangerous

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LIFEPAK 15 Part / Catalog Numbers / UDI-DI code: V15-7-000022 / 99577-001957 / 883873871690 V15-2-000051 / 99577-000046 / 883873988022 V15-2-000099 / 99577-000093 / 883873979020 V15-2-001603 / 99577-001256 / 883873911631 LIFEPAK 15: The LP15 is intended for use by trained medical personnel in out-of-doors and indoor emergency care settings within the environmental conditions specified in the Operating Instructions. The LP15 is designed to be used during ground transportation except when specified otherwise. Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients. Automated external defibrillation mode is intended for use on patients eight years of age and older.

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LIFEPAK 1000 Part / Catalog Numbers / UDI-DI code: 320371500023 / 99425-000025 / 885074698953 320371500229 / 99425-000025 / 885074698953 331706400001 / 99425-000025 / 885074698953 LIFEPAK 1000: The defibrillator is to be used in AED mode only on patients who are in cardiopulmonary arrest. The patient must be unresponsive, not breathing normally, and showing no signs of circulation. ECG monitoring is for use on conscious and unconscious patients of all ages for the purpose of ECG rhythm recognition and heart rate monitoring.

Physio-Control

Class I - Dangerous

Due to required inspections not being performed on products/units that have gone through servicing.

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