Stopcock, I.V. Set
FDA adverse event reports and recall history for stopcock, i.v. set (product code FMG), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 5,837
- Deaths
- 25
- Injuries
- 359
- Malfunctions
- 5,403
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2026-06-18Open, ClassifiedDevice Design
BD Connecta" BD Luer-Lok" 360 REF 394910 UDI-DI code: 00382903949106 BD Connecta" Stopcocks are used to administer fluids or medication through one or two different ports via an IV cannula or extension tube. The ports can be used to sample blood or for hemodynamic monitoring. When used with IV lipid nutritional products, the stopcock device can be used for up to 24 hours.
Due to stopcock issues when using the plastic luer-lok syringe, the connection at the Port C may over thread or continue to spin rather than tightening securely. This behavior has led some clinical users to perceive the connection as unstable.
- 2025-11-26Open, ClassifiedProcess control
Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15 DROPS/ML, 108 IN; Catalog Number: 490189. 2. IV ADMIN SET 137 IN.; Catalog Number: 490226.
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- 2025-11-26Open, ClassifiedProcess control
Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15 DROPS/ML, 132 IN; Catalog Number: 490469. 2. IV ADMIN SET, 60D 2 CARESITE VLV, 132 IN; Catalog Number: 490470.
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- 2025-11-26Open, ClassifiedProcess control
Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV AD. SET,15 DROPS/ML, W/EXT SET; Catalog Number: 490467.
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- 2025-11-26Open, ClassifiedProcess control
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/ 10 DROPS/ML, 134 in.; Catalog Number: 490357.
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- 2025-11-26Open, ClassifiedProcess control
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog numbers: 1. IV ADMIN SET, 10 DROPS/ML, 144 IN; Catalog Number: 490385. 2. IV ADMIN SET, 3 CARESITES, 120 IN.; Catalog Number: 490401.
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- 2025-11-26Open, ClassifiedProcess control
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. NF1270A SAFELINE ANESTHESIA IV SET; Anesthesia IV Administration Set with 3 CARESITE Injection Sites and Manifold; Catalog Number: NF1270A.
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- 2025-11-26Open, ClassifiedProcess control
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. US1295 ULTRASITE IV ADMIN SET 60DROP; Catalog Number: 352394.
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- 2025-11-26Open, ClassifiedProcess control
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV SET 15DR 5CARESITE 1 ULRAPORT, 141 IN; Catalog Number: 490067.
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- 2025-11-26Open, ClassifiedProcess control
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV SET W/2 CARESITE & 1 ULTRAPORT ZERO; ULTRAPORT Zer0 IV Set with CARESITE; Catalog Number: 457506.
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Monitor stopcock, i.v. set automatically
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