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Recall Observatory FDA recall evidence

Device product

VersaSafe Plastic Cannula - 11 Gauge, Model 9391-0200 Product Usage: Used with secondary IV sets or syringes with a female luer lock adapter to administer fluid and medications through a needle or catheter inserted into a patients artery or vein.

Z-3030-2017

June 30, 2017

Class II

Product summary

Firm
CareFusion 303, Inc.
Event
Event 77696
Status
Terminated
Classification
Class II
Quantity
1,546,800 units
Official record key
device-enforcement:Z-3030-2017

Official wording

Reason: Punctures in blister packaging that was detected during the packaging process.

Code information: Lot No. 1470303001, 1570314802, 1470303002, 1570317701, 1470304601, 1570317702, 1470306602, 1570317703, 1470306301, 1570317704, 1470306602, 1570322001, 1470311301, 1660771501, 1470306301, 1470311302, 1470314801

Distribution pattern: Worldwide Distribution in the states of : CO, IL, IN, MD, MI, NY, OH, & TX. and foreign countries of: Australia, New Zealand, & Japan.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Punctures in blister packaging that was detected during the packaging process.