Z-2883-2011

Arrow NextStep Antegrade Chronic Hemodialysis Catheter. Product is used for attaining long-term vascular...

Name: Z-2883-2011 Arrow NextStep Antegrade Chronic Hemodialysis Catheter. Product is used for attaining long-term vascular...
Creator: Arrow International Inc
Published: 2011-06-28
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2011-06-28 / Terminated / root cause: design

FDA source

Arrow International Inc began a recall of Arrow NextStep Antegrade Chronic Hemodialysis Catheter. Product is used for attaining long-term vascular access for hemodialysis and apheresis on 2011-06-28. The reason FDA records is "Firm has received complaints indicating breakage and/or separation of the stylet within the Arrow(R) NextStep(R) Antegrade Catheters". 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-2883-2011
Status: Terminated
Initiated: 2011-06-28
Posted: 2011-07-30
Terminated: 2012-04-16
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: Arrow NextStep Antegrade Chronic Hemodialysis Catheter. Product is used for attaining long-term vascular access for hemodialysis and apheresis.
Product code: MSD Catheter, Hemodialysis, Implanted
Reason for recall: Firm has received complaints indicating breakage and/or separation of the stylet within the Arrow(R) NextStep(R) Antegrade Catheters.
Root cause tag: design
FDA root cause: Device Design
Action: An "Urgent Medical Device Recall" letter dated June 28, 2011 was issued to consignees. The letter requested that customers check their stock, cease use and distribution, and quarantine all affected product. Consignees were further directed to complete the "Recall Acknowledgement & Stock Status Form", return the form to their sales representative, and return affected product as instructed on the letter. For questions or concerns, call 1-800-233-3187.
Quantity in commerce: 41
Distribution: United States (states of CA, DE, FL, MI, NC, and TN).
Product codes and lots: Product Number CS-15192-IXM, Lot Number RV1034909; Product Number CS-15232-IXM, Lot Number RV1034911; Product Number CS-15272-IXM, Lot Number RV1034912; Product Number CS-15312-IXM, Lot Number RV1034913; Product Number CS-15422-IX, Lot Number RV1034914; and Product Number CS-15502-IX, Lot Number RV1034915.

Product code MSD

K102238Class IIArrow(r) Nextstep Tm Antegrade Chronic Hemodialysis CatheterTeleflexmedical, Inc. / cleared 2011-02-01

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)