Portex LineDraw Arterial Blood Sampling Syringe with Dry Lithium Heparin for Gases and Electrolytes

FDA device recall Z-1715-2020 · posted 2020-04-15 · Terminated

Recall details

Recalling firm

Smiths Medical ASD, Inc.

Reason for recall

Portex Pro-Vent and LineDraw Arterial Blood Sampling syringes may have broken luers.

Action taken

The firm initiated the recall by letter on January 07, 2020. The "Urgent Medical Device Recall Notice", identified the removal of devices and instructed the customer to quarantine the affected products. The Notice provided the accompanying Recall Response Form to be completed and returned within 10 days of receipt to smithmedical4136@stericycle.com. The Notice details that the affected product must be returned to Stericycle for processing. The Notice instructed the distributor to notify their customers and to provide the customer a copy of the Recall Notice and Response Form. The Notice provided the contact email smithmedical4136@stericycle.com and phone number of 8669188738 for assistance.

Root cause

Process control

Status

Terminated

Product code

JKA

Quantity affected

720,100 total devices

Distribution

USA: AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI,MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA. Int'l: CA, DE, AU.

Date initiated

2020-01-07

Date posted

2020-04-15

Date terminated

2020-12-14

Location

Keene, NH

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