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Fanelli
COOK INCORPORATED · Model G12950 · UDI-DI 00827002129504
GBZ
Prescription
10
510(k) clearances
378
Adverse events (2 deaths)
24
Recalls
55
Facilities
Description
Fanelli Cholangiography Catheter Set
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-09-29 | Atrium Medical Corporation | A sterilization nonconformance prematurely aged the product, resulting in an inaccurate labeled expiration date. |
| 2022-04-21 | Atrium Medical Corporation | Mismatch between the expiration date on the sterile barrier pouch and the expiration date on the case/shipper label. Product sterile barrier pouch label expiration date of 16SEP202 |
| 2018-10-12 | Atrium Medical Corporation | This recall has been initiated in response to a seal defect found in certain sterile barrier pouches containing the device. Affected pouches are un-sealed at the bottom. If the pou |
| 2017-01-20 | Atrium Medical Corporation | Labeling icon depicts a catheter having six (6) eyelets; however the correct number of eyelets on the 8 Fr and 10 Fr thoracic catheters is two (2) |
| 2017-01-20 | Atrium Medical Corporation | Labeling icon depicts a catheter having six (6) eyelets; however the correct number of eyelets on the 8 Fr and 10 Fr thoracic catheters is two (2) |
| 2016-10-26 | Atrium Medical Corporation | Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains. |
| 2016-10-26 | Atrium Medical Corporation | Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains. |
| 2016-10-26 | Atrium Medical Corporation | Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains. |
| 2016-10-26 | Atrium Medical Corporation | Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains. |
| 2016-10-26 | Atrium Medical Corporation | Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.