CLASS II ONGOING Device recall · Reported 9 Sep 2020 · FDA Enforcement Report
Plastic Cannula Holdex recalled by C.A. Greiner & Sohne
C.A. Greiner & Sohne Gesellschaftmbh is recalling Plastic Cannula Holdex, distributed nationwide in the US. The recall was initiated on 27 Jul 2020 and the FDA has classified it as Class II.
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-2911-2020
- FDA event ID
- 86128
- Recalling firm
- C.A. Greiner & Sohne Gesellschaftmbh, Kremsmunster, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 27 Jul 2020
- FDA classified
- 28 Aug 2020
- Reported
- 9 Sep 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Heart & Vascular Devices
Timeline
| 27 Jul 2020 | Recall initiated by company | |
| 28 Aug 2020 | Classified by FDA | +32 days |
| 9 Sep 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Sample leaking from the sleeve covering the needle inside the cannula
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Plastic Cannula HOLDEX Item # 450216 - Product Usage: - Product Usage: It is intended for use in routine specimen withdrawal from specimen collection bags or bottles through needleless cannula ports.
Where it was distributed
US Nationwide distribution including in the states of UT, TN.
Questions about this recall
Is Plastic Cannula Holdex recalled?
Yes. C.A. Greiner & Sohne Gesellschaftmbh recalled Plastic Cannula Holdex on 27 Jul 2020. The recall is Class II and its status is Ongoing. Recall number Z-2911-2020.
Why was it recalled?
Sample leaking from the sleeve covering the needle inside the cannula
Which lots are affected?
Lot # A19073FK
Where was it sold?
US Nationwide distribution including in the states of UT, TN.
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
More recalls from C.A. Greiner & Sohne Gesellschaftmbh
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Vacuette Blood Transfer Unit recalled by C.A. Greiner & Sohne | C.A. Greiner & Sohne Gesellschaftmbh | Packaging Defects | N/A |
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 |