Smiths Medical ASD, Inc. Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes Catalog Number: 4589P-1 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes Catalog Number: 4589P-1
Brand
Smiths Medical ASD, Inc.
Lot Codes / Batch Numbers
Lot numbers starting with: 1, K1, K2, K50, K51, K52, K53, K541, K542, K543
Products Sold
Lot numbers starting with: 1, K1, K2, K50, K51, K52, K53, K541, K542, K543
Smiths Medical ASD, Inc. is recalling Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes Cat due to Sterility of the device is compromised due to packaging defects. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Sterility of the device is compromised due to packaging defects
Recommended Action
Per FDA guidance
Smiths Medical, ASD notified consignees by letter dated September 9, 2004 by FedEx. Customers and dealers are directed to fax back the attached Reply Letter to the Smiths Medical Regulatory Affairs Department at 603-358-1017, even if the customer/dealer no longer has affected products in inventory, Questions are directed to Customer Service at 1-800-258-5361, prompt 1. On 9/17/04, Smiths notified 48 consignees by Fed''X letter of 3 -additional lot codes for Product Code: 4252.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026