Reported Jul 22, 2020 · Terminated
POWERWAND XL 4Fr 8cm Maximum Barrier Kit (Introducer with an Extended Dwell Catheter made of ChronoFlex C with BioGUARD…
Access Scientific LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.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: Access Scientific LLC · 3910 Sorrento Valley Blvd Ste 200 · San Diego, CA · 92121-1419
Is this the product you have?
- POWERWAND XL 4Fr 8cm Maximum Barrier Kit (Introducer with an Extended Dwell Catheter made of ChronoFlex C with BioGUARD Technology), Catalog No. 94108, Device UDI 00859821006773/Pacakge
- UDI 10859821006770 - Product UsageIntroducer with Extended Dwell Catheter is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may also be used for power injection of contrast media up to a rate 8ml/sec, at a maximum of 325 psi fluid pressure
- Lot codes and dates
Lot number 269939270552270874and 272261
- Amount recalled
- 1710
Where it was sold
- Nationwide
- NY
Why it was recalled
Convenience kit mislabeled with the incorrect catheter effective length on the device label and the packaging label. Use may lead to a delay or interruption of treatment and user dissatisfaction or annoyance.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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