Recall Z-0843-2019 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Smiths Medical ASD Inc.
Aplicare Povidone Iodine Prep Pads packaged within Portex Pulsator Arterial Blood Sampling Kit with Liquid Sodium Heparin, models 4037NP-1, 4039-1, 4039EG-1, 4044EG-1, 4044P-1, 4057NP-1, 4067NP-1, 4077EG-1, 4077NP-1, 4084P-1, G1193, G1374, G1585, G1589, G1598, G1621, and G1806. The firm name on the label is Smiths Medical ASD, Inc., Keene, NH.
| 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 |