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FDA device recall Z-1051-2015 · posted 2015-02-06 · Terminated

Recall details

Recalling firm

Teleflex Medical

Reason for recall

Defects: Cracks that may occur in the center of the corrugated flex tube of the 15 mm and 22 mm ISO female connector.

Action taken

Consignees were notified by an Urgent - Field Safety Notice, dated 01/12/2015. The letter identified the affected devices, a description of the problem, and actions to be taken. Customers were asked to check their inventory for any affected product, to cease use and distribution, and immediately quarantine any affected product. Customers are to complete and return the Acknowledgement form and to their local MAQUET representative, who provide a return number. A credit will be issues upon receipt of the affected product. Customer should contact their local MAQUET representative at fieldactions@maquet.com with questions or for support this issue.

Root cause

Process control

Status

Terminated

Product code

BYD

Quantity affected

100 units

Distribution

Distributed to FL, KS, MI and WV.

Date initiated

2015-01-12

Date posted

2015-02-06

Date terminated

2016-05-10

Location

Durham, NC