Portex ProVent Arterial Blood Sampling Kit 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-1716-2020
- Quantity
- 127,700 total devices
- Firm Location
- Keene, NH
- Official Source
- View on FDA website ↗
Reason for Recall
Lots of Smiths Medical 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 Pro-Vent Arterial Blood Sampling Kit: Item Number Lot Number G1724 3859779 G1702 3863522 4599P-1 3859751 4599P-1 3862142 4599P-1 3863544 4599P-1 3863545 4599P-1 3869581 G1665 3856947 4588P-2 3862145 4558PE 3859727
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.