Drainage Bag…

Date posted by the FDA

June 2, 2011

Status

Terminated

Filed by

Remington Medical Inc.

Product

Drainage Bag, Model 600D, 600 mL, Single use, Ethylene Oxide sterilized, Remington Medical, Inc., 6830 Meadowridge Court, Alpharetta, GA 30005. The Biliary Drainage Bag is used to aid with fluid drainage involving abscess, biliary and nephrostomy. Mechanical failure of this device would result in patient discomfort. This device is not life sustaining no life supporting. The medical device is not intended to be implanted. This medical device has surface contact with the patient. Improper use of this device could cause fluid back-up and result in invasive contact through the catheter. The drainage bag will be used in conjunction with a nephrostomy/biliary drainage catheter.

Reason

There have been complaints of the Drainage Bags leaking from the outlet and the inlet port.

Distribution pattern

Nationwide Distribution

Quantity

89294 units

Codes and lots

Lot numbers: 082943, 083375, 083302, 083232 and 100904.

Recall started

Jan. 12, 2011

Device type

Bag, Bile Collecting

Root cause (FDA)

Other

What the company told customers

Remington Medical Inc.sent an Urgent Medical Device Recall letter dated January 12, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory and quarantine product subjec to recall. If they further distributed this product, they were to identify their customers and notify them at once of the product recall. Notification to their customers should include a copy of the recall notification letter. Customer were to receive a Return Authorization Form, reference RGA #600-D. For questions regarding this recall call 800-989-0057, ext. 213.

Recall number

Z-2405-2011

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-2405-2011. The agency record governs; check it and the company before acting.