Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2096-2015 — Safety PICC Insertion Tray with Chloraprep OneStep - Model #5026CL-9 - 12 pr case. Packaged for Physician use only.

U.S. FDA — Device Enforcement · United States · 2014-11-05 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2096-2015
Date of alert
2014-11-05
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Custom Healthcare Systems, Inc.
Product category
device
Product type
Devices
Reported risk: An INCORRECT item number is packed within the OUTSIDE "PIGGYBACKED" PACKAGE. The interior sealed STERILE KIT is correct and NO adverse issues affect that part of the item. The NON-STERILE OUTSIDE "PIGGYBACKED" PACKAGE mistakenly contains ITEM #8881579121 - Syringe prefilled, Saline Flush, 09% Sodium Chloride and is a NONSTERILE PRODUCT that CANNOT BE DROPPED INTO THE STERILE FIELD.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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