CLASS II Device recall · Reported 26 Feb 2020 · FDA Enforcement Report
Arrow Epidural Catheterization Kit Am recalled by Arrow International
Arrow International is recalling Arrow Epidural Catheterization Kit Am-05500, distributed nationwide in the US. The recall was initiated on 20 Dec 2019 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-1248-2020
- FDA event ID
- 84688
- Recalling firm
- Arrow International, Reading, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Dec 2019
- FDA classified
- 14 Feb 2020
- Reported
- 26 Feb 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 20 Dec 2019 | Recall initiated by company | |
| 14 Feb 2020 | Classified by FDA | +56 days |
| 26 Feb 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
Product lidstock contains the incorrect expiration date for the product
Product as listed by the FDA
Arrow EPIDURAL CATHETERIZATION KIT AM-05500
Where it was distributed
Nationwide Foreign: AT, AU, DE, CA, CZ, GT, NZ, PL, SK, and ZA
Questions about this recall
Is Arrow Epidural Catheterization Kit Am-05500 recalled?
Yes. Arrow International recalled Arrow Epidural Catheterization Kit Am-05500 on 20 Dec 2019. The recall is Class II and its status is Terminated. Recall number Z-1248-2020.
Why was it recalled?
Product lidstock contains the incorrect expiration date for the product
Which lots are affected?
Lot Number: 13F18A0745
Where was it sold?
Nationwide Foreign: AT, AU, DE, CA, CZ, GT, NZ, PL, SK, and ZA
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.
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| Device | CLASS I | Description/REF: Pacing PSI KIT: 6 FR/AI-06210-KS, Pacing PSI KIT recalled | Arrow International | Lead & Heavy Metals | Nationwide |
Other Heart & Vascular Devices recalls
All 6,190| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |