FDA Device Intelligence
Home › GBUK GROUP LIMITED › Enteral

Enteral

GBUK GROUP LIMITED · Model ABELDISO-PFCO-1 · UDI-DI 05060590884935

PNR
10
510(k) clearances
171
Adverse events (1 deaths)
4
Recalls
53
Facilities

Description

Enteral, ENFit Syringe, Amber Barrel, Single Use 1ml LDT

Recalls

DateFirmReason
2023-12-28Cardinal Health 200, LLCThe listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe enteral feeding pumps. As
2023-12-28Cardinal Health 200, LLCThe listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe enteral feeding pumps. As
2023-12-28Cardinal Health 200, LLCThe listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe enteral feeding pumps. As
2023-12-28Cardinal Health 200, LLCThe listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe enteral feeding pumps. As

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Data 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.