GALT VALVED TEARAWAY KIT GALT VTI w/ Sideport Stainless Steel Dbl Flex. J-St RX ONLY UNITS 1 STERILE EO Product Usage: U

FDA device recall Z-2589-2014 · posted 2014-09-04 · Terminated

Recall details

Recalling firm

Galt Medical Corporation

Reason for recall

The adhesive used in the product could dislodge when objects are inserted through the valve which could pose an embolic risk to the patient.

Action taken

Galt Medical sent an Urgent Medical Device Recall letters to all affected customers. The letter identified the affected product, reason for recall and actions to be taken. Customers were asked to identify and segregate the recalled lot (s) that is in their possession, complete and return the enclosed Recall Reply form, and return the recalled product to Galt Medical Corp. For questions contact your local sales representative or Recall Coordinator at 214-778-1306.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

DYB

Quantity affected

11,155 units in total

Distribution

Worldwide Distribution - US (nationwide) Canada, Germany, the Netherlands, Ireland, Switzerland, France, Italy, and Greece.

Date initiated

2014-07-25

Date posted

2014-09-04

Date terminated

2016-02-26

Location

Garland, TX

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