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Recall Observatory FDA recall evidence

Device product

PowerPICC SOLO Catheter with Sherlock 3CG TPS Stylet 4F Maximal Barrier Tray with Microintroducer 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-2047-2015

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-2047-2015

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: REYK1763, Item No. 1194108D

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.