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Gastrointestinal Tubes With Enteral Specific Connectors

FDA product code PIF · Class 2 · Gastroenterology, Urology

1,030
Registered devices
732
Adverse events
112
Recalls
50
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2026-02-10Boston Scientific CorporationRecall of kits which utilized ChloraPrep Triple Swabsticks from BD. Open or compromised seals on the sterile swabstick packaging, which could result in loss of
2024-11-26Applied Medical Technology IncThe extension sets subject to this recall have ENFit connections, although they should have non- ENFit connections. ENFit connectors will only fit with other EN
2024-02-20Boston Scientific CorporationInability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure
2024-02-20Boston Scientific CorporationInability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure
2023-12-19Boston Scientific CorporationAffected 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 defect
2019-03-20GETINGE US SALES LLCEdi Catheter labeled with wrong expiry date on single pack EDI catheter boxes
2015-12-23Xeridiem Mediem Medical Devices IncA feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected f
2015-12-23Xeridiem Mediem Medical Devices IncA feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected f
2015-12-23Xeridiem Mediem Medical Devices IncA feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected f
2015-12-23Xeridiem Mediem Medical Devices IncA feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected f

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.