STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20 STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP15 Defibril
Summary
The FDA issued a Class II for STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20 STERILIZABLE INTERNAL DEF by Physio-Control, Inc.. Reason: 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.
Details
Source
Device Recall
External ID
Z-0142-2025
Action Date
2024-10-30
Status
Ongoing
Category
device
Product 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.
Lot/Code Info: 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
Quantity Affected: 3,617 devices (US-3315 and O.U.S - 302 devices)
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.
Distribution
Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, and WV. The countries of Australia, Canada, Netherlands, and New Zealand.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-08-09
Company
Redmond, WA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 253 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Physio-Control, Inc. has 24 FDA actions in our database, including 22 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Physio-Control, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Physio-Control, Inc. have FDA actions?
Physio-Control, Inc. has 24 FDA actions in our database, including 22 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0142-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29