CLASS II Device recall · Reported 6 Mar 2019 · FDA Enforcement Report
AF 550 x/HR CPNB, Product recalled by Arrow International
Arrow International is recalling AF 550 x/HR CPNB, Product, distributed nationwide in the US. The recall was initiated on 2 Oct 2018 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-0949-2019
- FDA event ID
- 81375
- Recalling firm
- Arrow International, Reading, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Oct 2018
- FDA classified
- 25 Feb 2019
- Reported
- 6 Mar 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 2 Oct 2018 | Recall initiated by company | |
| 25 Feb 2019 | Classified by FDA | +146 days |
| 6 Mar 2019 | 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
Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is located. If the leak goes undetected it may result in a reduced level of drug delivery to the patient and consequently a lower level of pain relief than that prescribed or expected. This may result in the need for other, additional analgesic drug administration.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
AF 550 x 5ML/HR CPNB, Product code MC0050XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
Where it was distributed
Nationwide distribution.
Questions about this recall
Is AF 550 x/HR CPNB, Product recalled?
Yes. Arrow International recalled AF 550 x/HR CPNB, Product on 2 Oct 2018. The recall is Class II and its status is Terminated. Recall number Z-0949-2019.
Why was it recalled?
Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is located. If the leak goes undetected it may result in a reduced level of drug delivery to the patient and consequently a lower level of pain relief than that prescribed or expected. This may result in the need for other, additional analgesic drug administration.
Which lots are affected?
74C1601434 74E1602096 74C1602395 74F1602444 74C1703028 74F1700186 74D1700428 74G1702048 74D1701032
Where was it sold?
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 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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