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Recall Observatory FDA recall evidence

Device product

Scalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Peripherally Inserted Central Catheter

Z-0199-2023

February 24, 2021

Class II

Product summary

Firm
Access Vascular, Inc.
Event
Event 90981
Status
Terminated
Classification
Class II
Quantity
79 kits
Official record key
device-enforcement:Z-0199-2023

Official wording

Reason: Scalpel and StatLock components packaged with specific lots of the HydroPICC catheter have a shorter expiration date than what is listed on the outer kit package.

Code information: UDI-DI: 00862559000418 Catheter Kit Lots/Expiration Dates 09112001 Exp 9/24/2021 10212001 Exp 10/21/21 10282001 Exp 11/18/21 Scalpel Lots/Expiration Dates R18-08-010 Exp Feb-21 R19-01-009 Exp Jun-21 R20-01-010 Exp Aug-22 StatLock Lots/Expiration Dates R18-09-008 Exp 5/28/2021

Distribution pattern: Domestic distribution to NC, RI, NJ, and IL. No foreign distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Scalpel and StatLock components packaged with specific lots of the HydroPICC catheter have a shorter expiration date than what is listed on the outer kit package.