Z-1228-2017Class II

Vascular catheter introduction kit The PICC is indicated for short or long term peripheral access to the...

Name: Z-1228-2017 Vascular catheter introduction kit The PICC is indicated for short or long term peripheral access to the...
Creator: Arrow International Inc
Published: 2017-01-11
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2017-01-11 / Terminated / root cause: design

FDA source

Arrow International Inc began a recall of Vascular catheter introduction kit The PICC is indicated for short or long term peripheral access to the central Venous system for intravenous therapy, blood... on 2017-01-11. FDA classified it as Class II and gives the reason as "There have been complaints for peel away sheaths flaring". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1228-2017
Classification: Class II
Status: Terminated
Initiated: 2017-01-11
Posted: 2017-02-22
Terminated: 2018-09-06
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: Vascular catheter introduction kit The PICC is indicated for short or long term peripheral access to the central Venous system for intravenous therapy, blood sampling, infusion and power injection of contrast media.
Product code: LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Reason for recall: There have been complaints for peel away sheaths flaring
Root cause tag: design
FDA root cause: Device Design
Action: Arrow International mailed an Urgent Medical Device Advisory Notification letter to affected customers on 01/13/2017 to inform them of the issue. Customers with questions were instructed to contact their local sales representative or Customer Service at 1-866-246-6990.
Quantity in commerce: 215,703 units
Distribution: Nationwide Distribution
Product codes and lots: Material # ASK-01663-MST, ASK-04001-DU4, ASK-04001-DU5, PI-01351-LS, PI-01351-LS5, PI-01351-SS, PI-01552-LS, PI-01552-LS5, PI-01552-SS, PL-05041, PL-05041, PL-05052, PR-05041, PR-05041, PR-05041-T, PR-05042, ASK-01663-MST, ASK-04001-DU4, ASK-04001-DU5, PI-01351-LS, PI-01351-LS5, PI-01351-SS, PI-01351-SS, PI-01451-LS, PI-01451-LS5, PI-01451-SS, PI-01451-SS, PI-0-1552-LS

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1228-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1228-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-01	2017-02-22

Product code LJS

K930129Class IIArrow Picc-Peripherally Inserted Central CatheterArrow Intl., Inc. / cleared 1994-03-28

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

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)