Percutaneous Sheath Introducer Kit with Integral Hemostasis… recallZ-1158-2018 · Arrow International Inc · initiated Nov 14, 2017
Class II Terminated All recalls posted in March 2018
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Arrow International Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of best practices during central line insertions.
FDA root cause category: Labeling mix-ups
What the company is doing
On November 16, 2017, an Urgent Medical Device Notification titled "ARROW PSI and Pressure Injectable Multi-Lumen CVC Kits" was issued to customers informing them of the issue, and urging all to take the following actions: 1. Place a copy of this notification and the enclosed Central Line Insertion Checklist with each unit of affected product currently in your inventory. 2. Complete the enclosed Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or e-mail to [email protected]. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.
Recall details
- Recall number
- Z-1158-2018
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Nov 14, 2017
- Posted by the FDA
- Mar 5, 2018
- Recalling firm
- Arrow International Inc
- Quantity
- 18,124 total
- Product code
- DYB
- FDA submissions
- K780532
- Distribution
- Nationwide Distribution
Product description
Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters. Permits venous access and catheter introduction to the central circulation.
Code information (models, lots, serial numbers)
ASK-09903-ECL 23F16H0387 23F16H0595
Other devices under the same FDA submission
46 devices cleared under K780532 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ARROW IPN036824Teleflex Incorporated · INTRODUCER, CATHETER2 recalls2 reports
- ARROW IPN037025Teleflex Incorporated · INTRODUCER, CATHETER2 recalls0 reports
- ARROW IPN029661Teleflex Incorporated · INTRODUCER, CATHETER2 recalls0 reports
- ARROW IPN039798Teleflex Incorporated · INTRODUCER, CATHETER2 recalls0 reports
- ARROW IPN921749Teleflex Incorporated · INTRODUCER, CATHETER2 recalls0 reports
- ARROW IPN926611Teleflex Incorporated · Introducer, catheter2 recalls0 reports
- ARROW IPN036351Teleflex Incorporated · INTRODUCER, CATHETER1 recall2 reports
- ARROW IPN037011Teleflex Incorporated · INTRODUCER, CATHETER1 recall1 report
- ARROW IPN038521Teleflex Incorporated · INTRODUCER, CATHETER1 recall1 report
- ARROW IPN036682Teleflex Incorporated · INTRODUCER, CATHETER1 recall0 reports
- ARROW IPN036858Teleflex Incorporated · INTRODUCER, CATHETER1 recall0 reports
- ARROW IPN036931Teleflex Incorporated · INTRODUCER, CATHETER1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 79342).
- Z-1159-2018 · TerminatedPressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter, Sharps Safety Features and Maximal Barrier Precautions. Permits venous access and c…
- Z-1160-2018 · TerminatedPercutaneous Sheath Introducer Kit with ARROWg+ard Blue Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr…
- Z-1161-2018 · TerminatedPressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features, and Maximal Barrier Precautions.…
- Z-1162-2018 · TerminatedPressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS Catheter and Sharps Safety Features. Permits venous access to central c…
- Z-1163-2018 · TerminatedPressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS Catheter, Sharps Safety Features and Maximal Barrier Precautions. Permi…
- Z-1164-2018 · TerminatedPressure Injectable Two- Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS Catheter and Sharps Safety Features. Permits venous access to central cir…
- Z-1165-2018 · TerminatedPressure Injectable Multi- Lumen CVC Kit
- Z-1166-2018 · TerminatedARROWg+ard Blue PLUS Pressure Injectable Multi-Lumen CVC Kit. Intended to permit venous access to the central circulation.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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