Z-1716-2020 Class II Terminated
FDA device recall Z-1716-2020 was initiated by Smiths Medical ASD, Inc. on January 7, 2020 and is designated Class II. Reason for recall: Lots of Smiths Medical Portex Pro-Vent and LineDraw Arterial Blood Sampling syringes may have broken luers. The recall status is terminated (terminated December 14, 2020). Affected quantity: 127,700 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
- 127,700 total devices
Product Description
Portex ProVent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes
Reason for Recall
Lots of Smiths Medical 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 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