McKesson 191-MIS-1130Recalls & reported problems
Mckesson Medical-Surgical Inc. · Normal Saline IV Flush Syringe; 10 ml fill in 12ml Syringe · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- May 25, 2022Open, Classified
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
Z-1619-2022 · Root cause: Environmental control · FDA record ↗
Other Saline, Vascular Access Flush devices
- BD PosiFlush 306553Becton, Dickinson And Company · Saline, vascular access flush89 reports
- Excelsior 10011Medline Industries, Inc. · Saline, vascular access flush1 recall6 reports
- ARROW IPN927748Teleflex Incorporated · Saline, vascular access flush1 recall4 reports
- Halyard SS010Owens & Minor Distribution, Inc. · Saline, vascular access flush1 recall2 reports
- Normal Saline IV Flush Syringe 10mL in 12mL syringeMedefil, Inc. · Saline, Vascular Access Flush1 recall1 report
- Excelsior E0103-01Medline Industries, Inc. · Saline, vascular access flush1 recall1 report
- Halyard SS005Owens & Minor Distribution, Inc. · Saline, vascular access flush1 recall0 reports
- Halyard SS003Owens & Minor Distribution, Inc. · Saline, vascular access flush1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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