FDAClass IIJune 6, 2018

MAC(TM) Two-Lumen Central Venous Access Kit with recall: Sterility Concern

MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access Device, Integral Hemostasis Valve and Sharps Safety Features for use with…

Why was MAC(TM) Two-Lumen Central Venous Access Kit with recalled?

Product sterility may be compromised due to unsealed packaging.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Numbers: Product code ASK-21242-NYP: 13F17A0076 13F17B0076 13F17B0225 13F17E0773 13F17H0129 13F17J0020 13F17J0395 13F17L0012 Product code ASK-21242-PR: 13F17B0260 13F17F0591 13F17L0010 13F17L0273 13F17M0136

Product
MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access Device, Integral Hemostasis Valve and Sharps Safety Features for use with…
Recalling firm
Arrow International Inc
Quantity
416,055 total products
Distribution
US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM
Recall date
June 6, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls