CLASS II Device recall · Reported 20 Jun 2018 · FDA Enforcement Report
Rs Tandem 5f Dl Xpp recalled by Angiodynamics Inc. (Navilyst
Angiodynamics Inc. (Navilyst Medical Inc.) is recalling Rs Tandem 5f Dl Xpp, distributed in 34 states. The recall was initiated on 10 May 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-2200-2018
- FDA event ID
- 80169
- Recalling firm
- Angiodynamics Inc. (Navilyst Medical Inc.), Glens Falls, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 May 2018
- FDA classified
- 14 Jun 2018
- Reported
- 20 Jun 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 10 May 2018 | Recall initiated by company | |
| 14 Jun 2018 | Classified by FDA | +35 days |
| 20 Jun 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
Product as listed by the FDA
RS TANDEM 5F DL XPP, Catalog Number 60M019881
Where it was distributed
The products were distributed to the following US states: AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI, and WV. The products were distributed to the following foreign countries: Canada, China, Ireland, Spain.
ArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaFloridaGeorgiaIllinoisIndianaKansasKentuckyLouisianaMarylandMichiganMinnesotaMissouriMississippiMontanaNorth CarolinaNorth Dakota
Questions about this recall
Is Rs Tandem 5f Dl Xpp recalled?
Yes. Angiodynamics Inc. (Navilyst Medical Inc.) recalled Rs Tandem 5f Dl Xpp on 10 May 2018. The recall is Class II and its status is Terminated. Recall number Z-2200-2018.
Why was it recalled?
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
Which lots are affected?
UPN: H96560M0198811; Lot: 5299857
Where was it sold?
The products were distributed to the following US states: AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI, and WV. The products were distributed to the following foreign countries: Canada, China, Ireland, Spain.
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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