Micro Stream Filterline Infant/Neonatal products: Part # 010807 - VlTALINE H SET INFANT/NEONATAL 25UN (Inf/Neo Airway Ad

FDA device recall Z-2236-2011 · posted 2011-05-25 · Terminated

Recall details

Recalling firm

Oridion Medical 1987 Ltd.

Reason for recall

fine plastic strands on inner surface of the infant neonatal airway adapter may become dislodged and inhaled by the patient

Action taken

The firm, Oridion, sent an "Microstream Filterline Field Correction Notice" letter dated March 25, 2011 to its US and foreign customers via telephone, email with the documentation discussed in the call, and letter. The letter described the product, problem and actions to be taken. The customers were instructed to place all affected product held in their inventory on ship hold; gather these units in their inventory and at the customer sites and exchange with the new product; inspect filter line starter (sample) kits shipped with Capnostream 20 and Microcap patient monitors for affected product, if affected Infant/Neonatal filter lines are found, remove them from the starter (sample) kit; send a purchase order in order to obtain replacement product for units in their stock and at customers sites, and complete and return the Inventory Reporting Form Excel Spread Sheet within two weeks of receiving the email even if they or their customers do not have the affected inventory. Oridion shall conduct a removal of the products from the related production lots from the field and an immediate replacement with product from subsequent production lots that meet all requirements. This action will be conducted by Oridion's distributors or by Oridion directly in some cases. Oridion anticipates that new product will be available for shipment during the week of April 4th. Questions regarding the recall can be directed towards the Customer Service Coordinator at: 1-888-674-3466 x1234 or NA-FCA@oridion.com.

Root cause

Equipment maintenance

Status

Terminated

Product code

CCK

Quantity affected

300 units in US (12 boxes with 25 units ea)

Distribution

Worldwide distribution.

Date initiated

2011-03-25

Date posted

2011-05-25

Date terminated

2012-03-19

Location

Jerusalem, Har Hotzvim Industrial Park, Israel