Face Tent Hospilak Ref. No. 110-E, Face Tent, Adult No Tubing, Manufactured for Unomedical inc. Hospilak Ref. No. 111-E,

FDA device recall Z-1255-2011 · posted 2011-02-15 · Terminated

Recall details

Recalling firm

Convatec Inc.

Reason for recall

Face tents and Oxygen masks may have a sticky glue-like substance on the inside or outside of the mask consisting of dioctyl phthalate, epoxidized soybean oil and glycerol monoleate.

Action taken

Unomedical, Inc issued recall letters with attached return response forms dated January 7, 2011 via UPS. The letters request the customer stop use and quarantine product. The recall response form is to be completed and returned to Unomedical. The letters/return response form were also sent out in Spanish. Another recall letter was sent dated February 16, 2011 to capture additional lots that werent included in the initial letter.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

BYL

Quantity affected

1579100 pcs.

Distribution

Worldwide distribution, including USA, Puerto Rico, Canada, Mexico, Colombia, El Salvador, Paraguay, UK, Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Faroe Islands, Finland, France, Ger

Date initiated

2011-01-07

Date posted

2011-02-15

Date terminated

2013-02-27

Location

Skillman, NJ