Z-1716-2020Class II

Portex ProVent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes

Name: Z-1716-2020 Portex ProVent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes
Creator: Smiths Medical ASD, Inc.
Published: 2020-01-07
License: https://open.fda.gov/license/

Abbott Medical / initiated 2020-01-07 / Terminated / root cause: manufacturing process

FDA source

Smiths Medical ASD, Inc. began a recall of Portex ProVent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes on 2020-01-07. FDA classified it as Class II and gives the reason as "Lots of Smiths Medical Portex Pro-Vent and LineDraw Arterial Blood Sampling syringes may have broken luers". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1716-2020
Classification: Class II
Status: Terminated
Initiated: 2020-01-07
Posted: 2020-04-15
Terminated: 2020-12-14
Recalling firm: Abbott Medical
Product: Portex ProVent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Reason for recall: Lots of Smiths Medical Portex Pro-Vent and LineDraw Arterial Blood Sampling syringes may have broken luers.
Root cause tag: manufacturing process
FDA 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 [email protected]. 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 [email protected] and phone number of 8669188738 for assistance.
Quantity in commerce: 127,700 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.
Product codes and lots: Portex Pro-Vent Arterial Blood Sampling Kit: Item Number Lot Number G1724 3859779 G1702 3863522 4599P-1 3859751 4599P-1 3862142 4599P-1 3863544 4599P-1 3863545 4599P-1 3869581 G1665 3856947 4588P-2 3862145 4558PE 3859727

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1716-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1715-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-22	2020-04-15
Z-1716-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-22	2020-04-15

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)