Drainage Bag, Model 600D, 600 mL, Single use, Ethylene Oxide sterilized, Remington Medical, Inc., 6830 Meadowridge Court

FDA device recall Z-2405-2011 · posted 2011-06-02 · Terminated

Recall details

Recalling firm

Remington Medical Inc.

Reason for recall

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

Action taken

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.

Root cause

Other

Status

Terminated

Product code

EXF

Quantity affected

89294 units

Distribution

Nationwide Distribution

Date initiated

2011-01-12

Date posted

2011-06-02

Date terminated

2011-09-13

Location

Alpharetta, GA