CLASS II Device recall · Reported 6 Mar 2019 · FDA Enforcement Report
AF w/AS -,w/Y site,DL CPNB, Product recalled by Arrow International
Arrow International is recalling AF w/AS -,w/Y site,DL 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-0952-2019
- 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 w/AS 550 x 0.5-7 ml,w/Y site,DL CPNB, Product code MVAXL2Y CPNB, Arrow AutoFuser Disposable Pain Control Pump
Where it was distributed
Nationwide distribution.
Questions about this recall
Is AF w/AS -,w/Y site,DL CPNB, Product recalled?
Yes. Arrow International recalled AF w/AS -,w/Y site,DL CPNB, Product on 2 Oct 2018. The recall is Class II and its status is Terminated. Recall number Z-0952-2019.
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?
74A1600493 74E1701689 74A1701278 74F1601947 74B1700147 74G1601342 74B1700922 74H1601292 74C1601403 74H1602005 74C1601458 74J1601528 74C1601839 74K1601040 74C1602928 74K1601957 74C1702397 74L1601996 74D1600766 74L1602670 74E1600739 74M1501120 74E1601599 74M1600311 74E1700481 74M1600671
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.
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 |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |