Portex LineDraw Arterial Blood Sampling Syringe with Dry Lithium Heparin for Gases and Electrolytes
This recall has been terminated (originally issued April 15, 2020).
- Company
- Smiths Medical Asd, Inc.
- Recall Initiated
- January 7, 2020
- Posted
- April 15, 2020
- Terminated
- December 14, 2020
- Recall Number
- Z-1715-2020
- Quantity
- 720,100 total devices
- Firm Location
- Keene, NH
- Official Source
- View on FDA website ↗
Reason for Recall
Portex Pro-Vent and LineDraw Arterial Blood Sampling syringes may have broken luers.
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.
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
Root Cause
Process control
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.