Precept Medical Products, Foam Fog Shield Surgical Mask Green Fiberglass Free, REORDER #: 65-3320, non-sterile, 25/box,

FDA device recall Z-0154-2008 · posted 2007-12-28 · Terminated

Recall details

Recalling firm

Precept Medical Products, Inc.

Reason for recall

Small slits under the folds of the masks; thus they may not provide the protection necessary between the patient and surgical staff

Action taken

The firm notified its consignees on 09/14/2007 by Urgent Voluntary Medical Device Recall letter (USPS mail, certified, return-receipt requested). The recall was expanded on 10/04/2007 by Urgent Voluntary Medical Device Recall--Expansion Letter to include additional lots of product. Recall letters instruct users to cease use of devices and return them as well as conduct sub-recalls to the users level for any devices they have sub-distributed.

Root cause

Process control

Status

Terminated

Product code

FYA

Quantity affected

11,546,350 (both products-Z-0153/0154-2008)

Distribution

Worldwide; USA, Australia and Canada

Date initiated

2007-09-14

Date posted

2007-12-28

Date terminated

2009-09-11

Location

Arden, NC