PreludeEASE Hydrophilic Sheath Introducer Dilator The Merit PreludeEASE Hydrophilic Sheath Introducer is intended to pro

FDA device recall Z-0949-2017 · posted 2017-01-05 · Terminated

Recall details

Recalling firm

Merit Medical Systems, Inc.

Reason for recall

Recalling dilators included with the 6F PreludeEASE Hydrophilic Sheath Introducer because the dilator tips were manufactured with an undersized inner diameter and therefore will not allow passage of an 0.021 (0.53 mm) guide wire.

Action taken

Merit Medical sent an Urgent Product Recall Notice dated December 1, 2016, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to identify any affected devices within their facility, quarantine them, and discontinue use. Ensure that all personnel to whom the devices were distributed are made aware of this field action. Consignees were asked to work with their Merit Sales Representative to arrange product return. Consignees with questions were instructed to contact their Merit Sales Representative or Merit Customer Service at response@merit.com or at 801-208-4381. For questions regarding this recall call 801-208-4623.

Root cause

Process change control

Status

Terminated

Product code

DYB

Quantity affected

335

Distribution

Nationwide Distribution

Date initiated

2016-12-01

Date posted

2017-01-05

Date terminated

2017-04-18

Location

South Jordan, UT

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