Recall Z-0842-2019 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Smiths Medical ASD Inc.
Aplicare Povidone Iodine Prep Pads packaged within Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, models 4589P-1, 4591EG-1, 4591P-1, 4599P-1, 4611LH, 4611P-1, 4620EG-1, 4620P-1, 4640LH, 4640P-1, 4649P-1, 4660EG-1, 4660P-1, 4699LH, 4699P-1, G1325, G1412, G1481, G1509, G1548, G1581, G1586, G1602, G1627, G1632, G1634, G1671, G1675, G1716, G1724, G1773
| Date | Jun 22, 2018 |
| Status | Terminated |
| Reason | The povidone iodine prep pads packaged with the arterial blood sampling kits will not maintain the iodine potency through its labeled 36-month expiration dating. |
| Root cause | Under Investigation by firm |
| Action | The recalling firm issued letters via UPS tracked mail on 6/22/2018 and later again to additional customers on 7/19/2018. An amended letter was issued on 9/20/2018 via UPS tracked mail to include some model numbers that were inadvertently omitted in the previous letter issuance. |
| Quantity | Approx. 28,578,939 kits for both products |
| Distribution | Distribution was nationwide, including Puerto Rico. There was also military/government distribution. Foreign distribution was made to Canada, United Arab Emirates, Bahamas, Costa Rica, Latvia, and Saudi Arabia. |
| 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 |