CLASS III ONGOING Device recall · Reported 5 Oct 2022 · FDA Enforcement Report
Merit Medical Systems StayFIX Fixation Device recalled
Mckesson Medical-Surgical Inc. Corporate Office is recalling Merit Medical Systems StayFIX Fixation Device, Stayfix F/Percutan Cath, distributed nationwide in the US. The recall was initiated on 25 May 2022 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1797-2022
- FDA event ID
- 90731
- Recalling firm
- Mckesson Medical-Surgical Inc. Corporate Office, Richmond, VA
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 25 May 2022
- FDA classified
- 26 Sep 2022
- Reported
- 5 Oct 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Temperature Abuse
- Device type
- Heart & Vascular Devices
Timeline
| 25 May 2022 | Recall initiated by company | |
| 26 Sep 2022 | Classified by FDA | +124 days |
| 5 Oct 2022 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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. This device with this specific storage temperature deviation is not likely to cause adverse health consequences.
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
MERIT MEDICAL SYSTEMS StayFIX FIXATION DEVICE, STAYFIX F/PERCUTAN CATH 5FR-14FR Model Number: 884450023358. Used to secure anaesthesia catheter.
Where it was distributed
US Nationwide distribution.
Questions about this recall
Is Merit Medical Systems StayFIX Fixation Device, Stayfix F/Percutan Cath recalled?
Yes. Mckesson Medical-Surgical Inc. Corporate Office recalled Merit Medical Systems StayFIX Fixation Device, Stayfix F/Percutan Cath on 25 May 2022. The recall is Class III and its status is Ongoing. Recall number Z-1797-2022.
Why was it recalled?
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. This device with this specific storage temperature deviation is not likely to cause adverse health consequences.
Which lots are affected?
GTIN: 00884450023358; 10884450023355; 20884450023352
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |