Urethral Warmer System Model number FPRCH3001 The Urethral Warming System is designed to circulate a warm solution throu

FDA device recall Z-0832-2011 · posted 2010-12-29 · Terminated

Recall details

Recalling firm

Galil Medical

Reason for recall

This voluntary recall has been initiated because our supplier (Gaymar Industries, Inc.) notified us that these products contain power cords that may crack or fail at or inside the plug due to a prong design problem. Affected plugs can be identified by a round ground pin and black plastic bridges. Cords with plugs that are not affected have U-shaped ground pins and no plastic bridges. Although Gali

Action taken

Gaymar sent an URGENT: MEDICAL DEVICE RECALL letter dated September 30, 2010, to all consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to: Customers were instructed to: " Inspect units in their possession to determine if they contain affected power cord plugs or if there were any signs of excessive wear or damage. " Immediately discontinue use and quarantine the affected product. " Contact Customer Service Department at 800-828-7341 to arrange for replacement. " Complete the attached form for each unit and follow the instructions given to return the form by fax or e-mail. " If customers further distributed the product to another person or entity, they were to identify their customers and notify them at once of this product recall by including a copy of the recall notification letter and the attached form. For questions regarding this recall call 800-828-7341 or 716-662-2551.

Root cause

Other

Status

Terminated

Product code

GEH

Quantity affected

4

Distribution

Worldwide Distribution - USA, including CA, GA, TX and the country of Canada.

Date initiated

2010-11-11

Date posted

2010-12-29

Date terminated

2011-12-10

Location

Arden Hills, MN

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