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Terminated

Arrow(R) VPS(R) Access Kit for use with 4 and 5 Fr. Peripherally Inserted Central Venous Catheters

FDA Recall Z-2170-2017 · Posted None

Recalling FirmArrow International Inc
Recall StatusTerminated
Product CodeOBJ
Date Initiated2017-04-28
Date Terminated2018-08-03
Product Quantity3,918 units

Reason for Recall

Arrow International is notifying each customer who received the affected that product that the kits do not contain important information regarding the 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing.

Firm Action

Arrow International sent an Urgent Medical Device Notification letter dated May 2, 2017, to all affected customers to inform them of the issue. The letter will instruct the distributor to notify their customers if the product was further distributed and to return a completed acknowledgement form indicating the amount of units on hand. For further questions, please call (610) 378-0131.

Root Cause

Unknown/Undetermined by firm

Distribution Pattern

US Distribution to the state of : NC

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K103255VASCULAR POSITIONING SYSTEM TM (VPS TM SYSTEM) STYLETVasonova, Inc. · 2011-02-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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