Z-0842-2019Class II

Aplicare Povidone Iodine Prep Pads packaged within Portex Pro-Vent Arterial Blood Sampling Kit with Dry...

Name: Z-0842-2019 Aplicare Povidone Iodine Prep Pads packaged within Portex Pro-Vent Arterial Blood Sampling Kit with Dry...
Creator: Smiths Medical ASD Inc.
Published: 2018-06-22
License: https://open.fda.gov/license/

Abbott Medical / initiated 2018-06-22 / Terminated / root cause: labeling and UDI

FDA source

Smiths Medical ASD Inc. began a recall of Aplicare Povidone Iodine Prep Pads packaged within Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, models... on 2018-06-22. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0842-2019
Classification: Class II
Status: Terminated
Initiated: 2018-06-22
Posted: 2019-02-15
Terminated: 2020-10-05
Recalling firm: Abbott Medical
Product: 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, and G1807. The firm name on the label is Smiths Medical ASD, Inc., Keene, NH.
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Reason for recall: 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 tag: labeling and UDI
FDA 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 in commerce: 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.
Product codes and lots: Product with expiration dates between 11/30/2016 and 5/31/2020.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0842-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0842-2019	Class II	Terminated	Voluntary: Firm initiated	2019-02-27	2019-02-15
Z-0843-2019	Class II	Terminated	Voluntary: Firm initiated	2019-02-27	2019-02-15

Product code JKA

K952516Class IIPro-Vent, Line Draw, PulsatorSmiths Industries Medical Systems, Inc. / cleared 1995-07-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)