Reported Oct 30, 2024 · Ongoing
STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20 STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP15…
Physio-Control, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Physio-Control, Inc. · 11811 Willows Rd Ne · Redmond, WA · 98052-2003
Is this the product you have?
- 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 codes and dates
- LP20 Model/Catalog Number11131-000040
- UDI-DI codes00883873863558
- Part Number3317813-001
- Serial Numbers101648901 86557878 87141562 88458193 88482392 93989670
- Part Number3317813-005
- Serial Number107741863
- Model/Catalog Number11131-000041
- UDI-DI code00883873863534
- Part Number3317813-002
- Serial Numbers86287034 86949592 90445090 91624045 93441890
- Part Number3317813-006
- Serial Number107556559
- Model/Catalog Number11131-000042
- UDI-DI code00883873863527
- Part Number3317813-003
- Serial Numbers
100198569100759224101002312101042672101383090848301388488138284915416862402158626045386557878869495938779490890445091913805779218546296496375964963769649637797059498
- Part Number3317813-007
- Serial Numbers105817428 106332158 107556560
- Model/Catalog Number11131-000043
- UDI-DI code00883873863510
- Part Number3317813-004
- Serial Numbers101506304 86949594 90445092
- LP15 Model/Catalog Number11131-000044
- UDI-DI code00883873863503
- Part Number3317814-001
- Serial Numbers90445093 93441892 98719352 98719353 99649024 99649025
- Part Number3317814-005
- Serial Number107124577
- Model/Catalog Number11131-000045
- UDI-DI code00883873863497
- Part Number3317814-003
- Serial Numbers
10188846110188846210188846310210716910366933610366933710412508710412989210444060086280420904450959255651792871913958360409711138498719364987193659881363199692098
- Part Number3317814-007
- Serial Numbers106555464 106721716 106917875 106968460 107445069 107741891
- Model/Catalog Number11131-000046
- UDI-DI code00883873863480
- Part Number3317814-004
- Serial Numbers90445096 98719376 98813643 98990261 99692108
- Part Number3317814-008
- Serial Numbers107124605
- Model/Catalog Number11131-000047
- UDI-DI code00883873863213
- Part Number3317814-002
- Serial Numbers
848301419044509491515844925565169287191193441893987193589871935999692092
- Part Number3317814-006
- Serial Numbers107078533 107445059
- Amount recalled
- 3,617 devices (US-3315 and O.U.S - 302 devices)
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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