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Recall Observatory FDA recall evidence

Device product

PowerPICC SOLO2 Catheter 4F Maximal Barrier Tray with Microintroducer (Single-Lumen) (Sherlock) The PowerPICC Solo catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.

Z-2050-2015

May 27, 2015

Class III

Product summary

Firm
Bard Access Systems
Event
Event 71420
Status
Terminated
Classification
Class III
Quantity
N/A
Official record key
device-enforcement:Z-2050-2015

Official wording

Reason: Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates on the primary labeling.

Code information: Lot No: REYK1761, Item No. 9194108D

Distribution pattern: Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates on the primary labeling.