EchoTip Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012
Cook Medical Incorporated · Devices may contain elevated levels of bacterial endotoxin.
Open FDA's page for this record- Cfres ID
- 207156
- Product res number
- Z-1832-2024
- Event date initiated
- 2024-04-01
- Event date posted
- 2024-05-16
- Recall status
- Open, Classified
- Res event number
- 94395
- Product code
- FCG
- Product description
- EchoTip Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012
- Code info
- Catalogue Number: ECHO-HD-19-A; GPN: G52012; UDI/DI: 00827002520127; Lot Numbers: C2145003 and C2144407.
- Firm FEI number
- 3005580113
- Recalling firm
- Cook Medical Incorporated
- Address 1
- 400 N Daniels Way
- City
- Bloomington
- State
- IN
- Postal code
- 47404-9155
- Additional info contact
- Cook Medical Customer Relations Department 800-457-4500
- Reason for recall
- Devices may contain elevated levels of bacterial endotoxin.
- Root cause description
- Nonconforming Material/Component
- Product quantity
- 1 Unit OUS
- Distribution pattern
- International distribution in the countries of Germany, Netherlands, Switzerland, United Kingdom.
- Action
On April 01, 2024, Cook Ireland Ltd.(CIRL) initiated a field action for the EchoTip Ultra High Definition Ultrasound Access Needle (ECHO-HD-19-A) and EchoTip Ultra Endoscopic Ultrasound Needle (ECHO-19). Cook Ireland Ltd has identified 9 devices located outside of the United States (US) that are associated with the issue and has initiated a voluntary recall due to the potential of elevated levels of bacterial endotoxins on the devices. No US customers were impacted by this Field Safety Corrective Action (FSCA). No monitoring will be required as US consignees are not impacted by this recall. Effectiveness checks for this recall will not be necessary as US Consignees were not impacted by the distribution.
- K numbers
- K092359
- Harmonized identifiers (openFDA)
- Device name
- Biopsy Needle
- Medical specialty description
- Gastroenterology, Urology
- Regulation number
- 876.1075
- Device class
- 2
- K number
- K191472, K012864, K914732, K171596, K945921, K934370, K212822, K103694, K840354, K961897, K073399, K140137, K150891, K943304, K083802, K013356, K936194, K951598, K091257, K013070, K963565, K954155, K891777, K051506, K021525, K133763, K092359, K990220, K093195, K941563, K962568, K944944, K960317, K971842, K252646, K013109, K180449, K151738, K991672, K050120 +93 more
- Registration number
- 3015077548, 3004111573, 3044026004, 3010273872, 9615480, 1721686, 3010966701, 3001845648, 2183744, 3011642792, 3015972753, 3027641465, 1423507, 3015225571, 3009196578, 3006788678, 1417485, 3012494290, 1928237, 3016844398, 1211566, 9680269, 3003790304, 1058584, 2528981, 3011146996, 1625685, 9681260, 1820334, 1828132, 3011050570, 3018094310, 2030624, 1061124, 3007664053, 3008044552, 3015924373, 1320894, 3008773560, 3013440400 +89 more
- FEI number
- 3002807847, 3015077548, 3004111573, 3044026004, 3001451463, 3010273872, 1721686, 3010966701, 3001845648, 2183744, 3011642792, 3015972753, 3027641465, 3003705156, 3015225571, 3009196578, 3006788678, 1417485, 3012494290, 1928237, 3016844398, 1211566, 3003790304, 3003094851, 1000512168, 2528981, 3011146996, 1625685, 1820334, 1828132, 3011050570, 3002468371, 3018094310, 3007664053, 3008044552, 3015924373, 3005580113, 3008773560, 3013440400, 1721504 +89 more