CLASS II Device recall · Reported 18 Apr 2018 · FDA Enforcement Report
Multi-Lumen Hemodialysis Catheterization Kit recalled
Arrow International is recalling Multi-Lumen Hemodialysis Catheterization Kit for High Volume Infusions, distributed in District of Columbia. The recall was initiated on 22 Dec 2017 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-1328-2018
- FDA event ID
- 79512
- Recalling firm
- Arrow International, Reading, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Dec 2017
- FDA classified
- 10 Apr 2018
- Reported
- 18 Apr 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 22 Dec 2017 | Recall initiated by company | |
| 10 Apr 2018 | Classified by FDA | +109 days |
| 18 Apr 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Multi-Lumen Hemodialysis Catheterization Kit for High Volume Infusions, Part Number: CDC-12123-P1A
Where it was distributed
Distributed in all 50 U.S. states and the District of Columbia. Distributed in Bahamas, Canada, Mexico, Panama, and Singapore.
Questions about this recall
Is Multi-Lumen Hemodialysis Catheterization Kit for High Volume Infusions recalled?
Yes. Arrow International recalled Multi-Lumen Hemodialysis Catheterization Kit for High Volume Infusions on 22 Dec 2017. The recall is Class II and its status is Terminated. Recall number Z-1328-2018.
Why was it recalled?
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
Which lots are affected?
Lot Number: 13F17F0081
Where was it sold?
Distributed in all 50 U.S. states and the District of Columbia. Distributed in Bahamas, Canada, Mexico, Panama, and Singapore.
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 Arrow International
All 525| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Description/REF: Agba Picc G4 Stylet: 3L 6FR x 55CM recalled | Arrow International | Lead & Heavy Metals | Nationwide |
| Device | CLASS I | Description/REF: Hemodialysis KIT: 2-Lumen 8 FR X 11 CM/AK-11802-F recalled | Arrow International | Lead & Heavy Metals | Nationwide |
| Device | CLASS I | Description/REF: PI CVC KIT recalled by Arrow International | Arrow International | Lead & Heavy Metals | Nationwide |
| Device | CLASS I | Description/REF: PI Picc: 3: 6FR x 55CM w CHG/ Dlx-35563-Hpkc; Agba recalled | Arrow International | Lead & Heavy Metals | Nationwide |
| Device | CLASS I | Description/REF: Pacing PSI KIT: 6 FR/AI-06210-KS, Pacing PSI KIT recalled | Arrow International | Lead & Heavy Metals | Nationwide |
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| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |