Z-1715-2020 Class II Terminated
FDA device recall Z-1715-2020 was initiated by Smiths Medical ASD, Inc. on January 7, 2020 and is designated Class II. Reason for recall: Portex Pro-Vent and LineDraw Arterial Blood Sampling syringes may have broken luers. The recall status is terminated (terminated December 14, 2020). Affected quantity: 720,100 total devices.
Recall Details
- Product Type
- Devices
- Report Date
- April 22, 2020
- Initiation Date
- January 7, 2020
- Termination Date
- December 14, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 720,100 total devices
Product Description
Portex LineDraw Arterial Blood Sampling Syringe with Dry Lithium Heparin for Gases and Electrolytes
Reason for Recall
Portex Pro-Vent and LineDraw Arterial Blood Sampling syringes may have broken luers.
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.
Code Information
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