# FDA recall Z-1335-2018

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

## Product

AGB+ Multi Lumen CVC Kit (1) Part Number (PN): CDC-42703-B1A, (2) PN: CDC-42802-1A, (3) CDC-45703-1A, (4) CDC-45703-A1A, (5) PN: CDC-45703-B1A; AGB+ Quad-Lumen CVC Kit (6) PN: CDC-42854-1A, (7) PN: CDC-45854-1A; AGB+ Two-Lumen CVC Kit (8) PN: CDC-45802-1A, (9) PN: CDC-45802-B1A, (10) PN: CDC-46702-1A, (11) CDC-47702-1A; (12) Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features, PN: ASK-45703-AH

## 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-1335-2018
- **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-1335-2018

## Citation

> AI Analytics. FDA recall Z-1335-2018. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-1335-2018. Source: US FDA. Licensed CC0.

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