LUCAS 2 Model Number: 99576 Catalog Numbers: 99576-000024 and 99576-000011 UD...
Reason for Recall / Hazard
Due to a subset of chest compression systems/devices where the service performed on the systems were not appropriately documented (The documents for the service performed to justify the passing results were not include in the service records).
Product Description & Identification
LUCAS 2 Model Number: 99576 Catalog Numbers: 99576-000024 and 99576-000011 UDI-DI code: 00883873904565 LUCAS 3 Model Number: 99576 Catalog Number: 99576-000043 UDI-DI code: 00883873861875 LUCAS 3.1 Model Number: 99576 Catalog Number: 99576-000063 UDI-DI code: 00883873834329 LUCAS chest compression System is to be used for performing external cardiac compressions on adult patients who have acute circulatory arrest defined as absence of spontaneous breathing and pulse, and loss of consciousness.
Affected Products
LUCAS 2 Model Number: 99576 Catalog Numbers: 99576-000024 and 99576-000011 UDI-DI code: 00883873904565 LUCAS 3 Model Number: 99576 Catalog Number: 99576-000043 UDI-DI code: 00883873861875 LUCAS 3.1 Model Number: 99576 Catalog Number: 99576-000063 UDI-DI code: 00883873834329 LUCAS chest compression System is to be used for performing external cardiac compressions on adult patients who have acute circulatory arrest defined as absence of spontaneous breathing and pulse, and loss of consciousness.
Additional Source Details
| Field | Value |
|---|---|
| City | Lund |
| Event id | 98417 |
| Address 1 | Scheelevagen 17 |
| Address 2 | Ideon Science Park |
| Code info | LUCAS 2 Model Number: 99576 Catalog Numbers: 99576-000024 and 99576-000011 UDI-DI code: 00883873904565 Serial Numbers: 30100846 30112125 30123845 30124348 30124440 30124475 30124991 30136605 30148155 30148365 3015B568 3015B682 3015C276 3015C722 3015C723 3015C724 3015F246 3015F587 3016G845 3016H983 3017K078 3017K079 3017K080 LUCAS 3 Model Number: 99576 Catalog Number: 99576-000043 UDI-DI code: 00883873861875 Serial Numbers: 35160778 35173272 35173461 35185820 35185817 35175040 35175039 35173347 35160921 35175373 35174279 35172701 35161449 LUCAS 3.1 Model Number: 99576 Catalog Number: 99576-000063 UDI-DI code: 00883873834329 Serial Numbers: 3520R763 3522AN95 3519F615 3520N419 3522DK48 3521S574 3521T901 3520R187 3518B300 3522EG06 3520P749 3520R206 3520S005 3520P512 3520P691 3520P741 3520P742 3520P744 3520P745 3520P746 3520P748 3520P810 3520S006 3520P747 3520S003 3521AF21 3518B131 3520L408 3519E743 3521AC18 3521U379 3520O364 3520S292 3519F035 3520S149 3521Z495 3521Z496 3520P082 3520L957... [TRUNCATED] |
| Postal code | N/A |
| Report date | 20260520 |
| Product type | Devices |
| Product quantity | 153 systems |
| Reason for recall | Due to a subset of chest compression systems/devices where the service performed on the systems were not appropriately documented (The documents for the service performed to justify the passing results were not include in the service records). |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260413 |
| Initial firm notification | Letter |
| Center classification date | 20260511 |
Overview
- Recalling FirmJolife AB
- StatusOngoing
- Risk LevelClass II
- DistributionU.S. Nationwide distribution in the states of AL, AZ, CA, FL, HI, IA, KS, KY, LA, MA, MD, MN, NC, NV, OH, SC, TX, UT, VA, WA, and WY.