Recalls / —

—#179021

Product

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

FDA product code

JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection

Device class

Class 2

Medical specialty

Clinical Chemistry

510(k) numbers

K952516

Affected lot / code info

Portex LineDraw Arterial Blood Sampling Syringe: Item Number Lot Number 4042-2 3848838 4042-2 3848878 4042-2 3856950 4042-2 3859774 4042LH 3856958 4042LH 3859747

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm

Smiths Medical ASD, Inc.

Address

10 Bowman Dr, Keene, New Hampshire 03431-5043

Distribution

Distribution pattern

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.

Timeline

Recall initiated

2020-01-07

Posted by FDA

2020-04-15

Terminated

2020-12-14

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #179021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.