—#166689

Product

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.

FDA product code: JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K952516
Affected lot / code info: Product with expiration dates between 11/30/2016 and 5/31/2020.

Why it was recalled

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 (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Smiths Medical ASD Inc.
Address: 6000 Nathan Ln N, Minneapolis, Minnesota 55442-1690

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2018-06-22
Terminated: 2020-10-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #166689. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.