FDA Medical Device Recalls (openFDA)
Smiths Medical ASD, Inc.: Portex LineDraw Arterial Blood Sampling Syringe with Dry Lithium Heparin for Gases and Electrolytes
- Recall number
- Z-1715-2020
- Recalling firm
- Smiths Medical ASD, Inc.
- Product
- Portex LineDraw Arterial Blood Sampling Syringe with Dry Lithium Heparin for Gases and Electrolytes
- Status
- Terminated
- Initiated
- 2020-01-07
- Posted
- 2020-04-15
- Terminated
- 2020-12-14
- Reason
- Portex Pro-Vent and LineDraw Arterial Blood Sampling syringes may have broken luers.
- Root cause
- Process control
- Action
- The firm initiated the recall by letter on January 07, 2020. The "Urgent Medical Device Recall Notice", identified the removal of devices and instructed the customer to quarantine the affected products. The Notice provided the accompanying Recall Response Form to be completed and returned within 10 days of receipt to smithmedical4136@stericycle.com. The Notice details that the affected product must be returned to Stericycle for processing. The Notice instructed the distributor to notify their customers and to provide the customer a copy of the Recall Notice and Response Form. The Notice provided the contact email smithmedical4136@stericycle.com and phone number of 8669188738 for assistance.
- Quantity
- 720,100 total devices
- Distribution
- USA: AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI,MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA. Int'l: CA, DE, AU.
- Lot, serial or model codes
- Portex LineDraw Arterial Blood Sampling Syringe: Item Number Lot Number 4042-2 3848838 4042-2 3848878 4042-2 3856950 4042-2 3859774 4042LH 3856958 4042LH 3859747
- 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