(1) Central Venous Catheterization Kit, Part Number (PN): ASK-04300-PHP; (2) Single-Lumen Central...

FDA Recall #Z-1331-2018 — Class II — December 22, 2017

Recall #Z-1331-2018 Date: December 22, 2017 Classification: Class II Status: Terminated

Product Description

(1) Central Venous Catheterization Kit, Part Number (PN): ASK-04300-PHP; (2) Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, PN: ASK-04301-WBH; (3) Vessel Catheterization Kit, PN: ASK-04550-NYP

Reason for Recall

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

Recalling Firm

Arrow International Inc — Reading, PA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Distribution

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

Code Information

Lot Numbers: (1) 13F17D0048; (2) 13F17E0659; (3) 13F17A0075, 13F17C0503, 13F17D0296, 13F17E0541, 13F17F0220, 13F17G0002

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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