FDA Medical Device Recalls (openFDA)
Smiths Medical ASD, Inc.: Portex Custom Pro-Vent Arterial Blood Sampling Kit Catalog Number: G1696
- Recall number
- Z-0254-05
- Recalling firm
- Smiths Medical ASD, Inc.
- Product
- Portex Custom Pro-Vent Arterial Blood Sampling Kit Catalog Number: G1696
- Status
- Terminated
- Initiated
- 2004-09-09
- Posted
- 2004-11-24
- Terminated
- 2012-05-08
- Reason
- Sterility of the device is compromised due to packaging defects
- Root cause
- Other
- Action
- 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.
- Quantity
- not on file
- Distribution
- Nationwide
- Lot, serial or model codes
- Lot number: K513947
- 510(k) numbers
- ["K952516"]
- PMA numbers
- not on file
- Product code
- JKA
- Firm FEI
- 1217052
- Firm city
- Keene
- Firm state
- NH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28