Reported Mar 6, 2019 · Terminated
AF550x5ML/H 2ML 60LO 6" CATH, 4.5" IN, Product code MT5060XLSK5 CP, Arrow AutoFuser Disposable Pain Control Pump
Arrow International Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Arrow International Inc · 2400 Bernville Rd · Reading, PA · 19605-9607
Is this the product you have?
AF550x5ML/H 2ML 60LO 6" CATH4.5" INProduct code MT5060XLSK5 CPArrow AutoFuser Disposable Pain Control Pump
- Lot codes and dates
74A180188974H170017174F170018374H170190374F170196574H170313374F170267874K1700663
- Amount recalled
- 8
This recall covers 17 products
The agency filed one notice per product. You are reading one of them; the other 16 are below.
4 more are in the archive.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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