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

FDA device recall Z-0914-2013 · posted 2013-03-06 · Terminated

Recall details

Recalling firm

Churchill Medical Systems, Inc.

Reason for recall

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.

Action taken

Vycon sent an Urgent Medical Device Recall letter dated January 21, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed check their stock for the affected product and immediately cease use and distribution and quarantine all affected product immediately. Count and document their affected inventory on the Recall Acknowledgement and Inventory Return Form. Customers were instructed to fax or email the form to Vygon including customer contact information. All affected product would be credited or replaced at no cost to the customer. Customers with questions were instructed to call 1-800-473-5414, or by e-mail at customerservice@vygonus.com. For questions regarding this recall call 603-743-5988.

Root cause

Under Investigation by firm

Status

Terminated

Product code

FPA

Quantity affected

2340

Distribution

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

Date initiated

2013-01-21

Date posted

2013-03-06

Date terminated

2013-09-10

Location

Dover, NH

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