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Enteral
GBUK ENTERAL LIMITED · Model NC08.050ISOSAF-ROW · UDI-DI 05060460844366
10
510(k) clearances
732
Adverse events (23 deaths)
112
Recalls
86
Facilities
Description
Enteral, Feeding Tubes, Nutricare, Single Use Rest-of-World 8Fr x 50cm
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-02-10 | Boston Scientific Corporation | Recall of kits which utilized ChloraPrep Triple Swabsticks from BD. Open or compromised seals on the sterile swabstick packaging, which could result in loss of sterility or drying |
| 2024-11-26 | Applied Medical Technology Inc | The extension sets subject to this recall have ENFit connections, although they should have non- ENFit connections. ENFit connectors will only fit with other ENFit-compatible devic |
| 2024-02-20 | Boston Scientific Corporation | Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the devi |
| 2024-02-20 | Boston Scientific Corporation | Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the devi |
| 2023-12-19 | Boston Scientific Corporation | Affected batches of the kit contain Stoma Measuring Devices sized to measure for an 18/24F replacement button, but are labeled as being for a 28F. Use of defective product may lead |
| 2019-03-20 | GETINGE US SALES LLC | Edi Catheter labeled with wrong expiry date on single pack EDI catheter boxes |
| 2015-12-23 | Xeridiem Mediem Medical Devices Inc | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile |
| 2015-12-23 | Xeridiem Mediem Medical Devices Inc | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile |
| 2015-12-23 | Xeridiem Mediem Medical Devices Inc | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile |
| 2015-12-23 | Xeridiem Mediem Medical Devices Inc | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile |
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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.