ARTERIAL SET-UP W/03ML FLUSH DEVICE FOR ORLANDO REG. MED. CTR., Item No. 46068-49 The Transpac Disposable Straight Press

FDA device recall Z-0475-2017 · posted 2016-11-15 · Terminated

Recall details

Recalling firm

ICU Medical, Inc.

Reason for recall

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Action taken

ICU Medical sent an Urgent Medical Device Recall Notification letter dated September 27, 2016, to all affected customers to inform them of the expanded recall of the monitoring kits with Transpac IV transducers. Customers were informed of updated communications from August 10, 2016, when ICU Medical sent a communication indicating a potential leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. Based on continued evaluation, ICU Medical is expanding the notification to now include certain other monitoring kits that contain the Transpac IV transducers. A small number of these devices may have the potential to leak or potentially introduce small amounts of air into the line. Customers with questions were instructed to contact ICU Customer Service Monday through Friday between the hours of 8:30 AM and 4:00 PM Pacific time: 866-829-9025 and select option 2, or e-mail the following address: productreturns@icumed.com. Customers are instructed to complete the attached Medical Device Recall Response Form and fax to (801) 264-1755 or e-mail to recall@icumed.com. Customers with questions were instructed to call 866-829-9025.

Root cause

Device Design

Status

Terminated

Product code

DRS

Quantity affected

200 units

Distribution

Nationwide Distribution

Date initiated

2016-09-27

Date posted

2016-11-15

Date terminated

2017-07-11

Location

San Clemente, CA

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