Recall Z-1716-2020 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Smiths Medical ASD, Inc.
Portex ProVent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes
| Date | Apr 15, 2020 (initiated Jan 7, 2020) |
| Status | Terminated |
| Reason | Lots of Smiths Medical Portex Pro-Vent and LineDraw Arterial Blood Sampling syringes may have broken luers. |
| Root cause | Process control |
| Action | 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 pr |
| Quantity | 127,700 total devices |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K952516 | PRO-VENT, LINE DRAW, PULSATOR Smiths Industries Medical Systems, Inc., Jul 14, 1995 |