FDA Device Recall Z-0021-2018: OriGen Biomedical, Inc.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0021-2018.

Recall Res Number

Z-0021-2018

Recalling Firm / Manufacturer

OriGen Biomedical, Inc.

FEI Number

1000160256

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2017-08-02

Date Posted

2017-10-20

Date Terminated

2024-02-29

Product Code

DWF

Event Number

78033

Product Quantity

180 units

Product Description The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on the tip of the device. A thin sheath is used to cover and secure the wire layer and is heat shrunk into a permanent position.

Reason for Recall Two users have reported to OriGen that a VV28F OriGen Reinforced Dual Lumen ECMO Catheter has had a separation of the clear extension tube from the hub connection. These adverse events resulted in patient injury (blood loss).

Action Details The firm initiated their recall by letter on 08/02/2017, following with a press release on 08/28/2017. The firm sent a revised letter to include instructions for the distributors on 09/22/2017 and an updated press release was sent on 09/26/2017. The firm requested that the consignee discontinue use of all OriGen VV28F Reinforced Dual Lumen ECMO Catheters from lots N18487 and N18487-1 and return any of those lots to OriGen Biomedical immediately for replacement or product credit.

Distribution Pattern US Nationwide and the countries of Austria, Belgium, Chile, Czech Republic, Italy, Kingdom of Saudi Arabia, Netherlands, Poland, Sweden, Thailand, Colombia, India, South Africa, United Arab Emirates.

Code Information / Serial Numbers Lot Numbers: N18487, N18487-1

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Medical Device Recall: Z-0021-2018

Recall Parameters & Description

Related Establishments / Registrations

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