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Recall Observatory FDA recall evidence

Device product

Lifeguard Infusion Set with Smartsite, 20Ga, 1, CLGY-2010 Huber type needle set used for the infusion of medical fluids into implantable ports.

Z-0914-2013

January 21, 2013

Class II

Product summary

Firm
Churchill Medical Systems, Inc.
Event
Event 64464
Status
Terminated
Classification
Class II
Quantity
2340
Official record key
device-enforcement:Z-0914-2013

Official wording

Reason: The label on the device states that the item number is CLGY-2210 when the item number on the device label should read CLGY-2010. This is a 20Ga Huber needle set; however, the product label states the pouch contains a 22Ga set.

Code information: Lot #1210099

Distribution pattern: Nationwide Distribution including MO, IL, FL, PA, VA, MO, NY, NE, NH, and OH.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The label on the device states that the item number is CLGY-2210 when the item number on the device label should read CLGY-2010. This is a 20Ga Huber needle set; however, the product label states the pouch contains a 22Ga set.