# FDA recall Z-1329-2018

> **Arrow International Inc** · Class II · device recall initiated 2017-12-22.

## Product

(1) 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, Part Number: ASK-09803-WBH1; (2) 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, Part Number: ASK-09903-KH; (3) Percutaneous Sheath Introducer Kit for use with 7.5 - 8 Fr.  Catheters, Part Number: ASK-09903-LC; (4) PSI Kit for use with 7.5 - 8 Fr. Catheters, Part Number: ASK-09903-PHP; (5) Percutaneous Sheath Introducer Kit for use with 7.5 - 8 Fr. Catheters, Part Number: ASK-09907-LGH1; (6) Arrow PSI Kit, Part Number: CDC-09803-1A; (7) Arrow PSI Kit, Part Number: CDC-09903-1A

## Reason for recall

Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.

## Distribution

Distributed in all 50 U.S. states and the District of Columbia. Distributed in Bahamas, Canada, Mexico, Panama, and Singapore.

## Key facts

- **Recall number:** Z-1329-2018
- **Recalling firm:** Arrow International Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-12-22
- **Report date:** 2018-04-18
- **Termination date:** 2020-05-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Reading, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1329-2018

## Citation

> AI Analytics. FDA recall Z-1329-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1329-2018. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*