Recalls / —

—#26079

Product

Sterile 8 Fr Suction Catheter Kit - Latex Free; Medline Industries, Inc., Mundelein, IL 60060-4488; 50 kits per case

FDA product code

GBX — Catheter, Irrigation

Device class

Class 1

Medical specialty

General, Plastic Surgery

510(k) numbers

K822510

Affected lot / code info

reorder #DYND40978, lot 02IA0387

Why it was recalled

Some of the kits labeled as latex free contain latex gloves which are properly labeled.

Root cause (FDA determination)

Other

Action the firm took

Recalled by letter dated 2/11/03. The accounts were informed that some of the suction catheter trays labeled as latex free actually contained latex gloves. The latex glove wrapper has a latex warning on it. The accounts were instructed to return any of the suspect lot of trays to Medline for replacement or credit. The recall was expanded by letterdated 3/3/03 to include the one lot of dressing change trays for the same problem and the same instructions.

Recalling firm

Firm

Medline Industries Inc

Address

One Medline Place, Mundelein, Illinois 60060

Distribution

Distribution pattern

Nationwide and Canada

Timeline

Recall initiated

2003-02-12

Posted by FDA

2003-03-12

Terminated

2003-08-12

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #26079. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.