Precept Medical Products, Inc.: Precept Medical Products, Tape Fog Shield Surgical Mask Green Fiberglass Free, REORDER #: 65-3322, non-sterile, 50/box, 5 box/case, Precept Medical Products, Inc., Arden, NC 28704, 1-800-438-5827, Mexico

Recall number

Z-0153-2008

Recalling firm

Precept Medical Products, Inc.

Product

Precept Medical Products, Tape Fog Shield Surgical Mask Green Fiberglass Free, REORDER #: 65-3322, non-sterile, 50/box, 5 box/case, Precept Medical Products, Inc., Arden, NC 28704, 1-800-438-5827, Mexico

Status

Terminated

Initiated

2007-09-14

Posted

2007-12-28

Terminated

2009-09-11

Reason

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

Root cause

Process control

Action

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.

Quantity

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

Distribution

Worldwide; USA, Australia and Canada

Lot, serial or model codes

Lot Numbers: 1053430 through 1061090, and 1060180, 1060190, 1060200, 1060230, 1060240, 1060250, 1060260, 1060270, 1060300, 1060310, 1060320, 1060440, 1060450, 1060460, 1060470, 1060480, 1060510, 1060520, 1060530, 1060660, 1060670, 1060680, 1060970, 1061000, 1061240, 1061250, 1061350, 1061360, 1061370, 1061390, 1061420, 1061440, 1061450, 1061530, 1061560, 1061570, 1061580, 1061590, 1061630, 1061640, 1061650, 1061670, 1061710, 1071720, 1061730, 1061790, 1061800, 1061810, 1061840, 1061850, 1061860, 1061870, 1062010, 1062020, 1062060, 1062070, 1062090, 1062120, 1062130, 1062190, 1062200, 1062210, 1062220, 1062360, 1062370, 1062390, 1062400, 1062440, 1062470, 1062510, 1062540, 1062560, 1062570, 1062580, 1062690, 1062700, 1062710, 1062720, 1062760, 1062770, 1062780, 1062790, 1062820, 1062850, 1062860, 1062890, 1062900, 1062910, 1062970, 1062980, 1063030, 1063040, 1063050, 1063060, 1063180, 1063190, 1063200, 1063260, 1063270, 1063280, 1063290, 1063330, 1063390, 1063400, 1063410, 1063420, 1063430, 1063450, 1063460, 1063470, 1063480, 1063500, 1070080, 1070090, 1070110, 1070120, 1070290, 1070300, 1070310, 1070320, 1070460, 1070470, 1070500, 1070510, 1070520, 1070530, 1070540, 1070600, 1070640, 1070650, 1070660, 1070850, 1070860, 1070870, 1070880, 1071000, 1071310, 1071430, 1071440, 1071450, 1071460, 1071480, 1071490, 1071500, 1071510, 1071520, 1071530, 1071550, 1071620, 1071650, 1071660, 1071670, 1071690, 1071700, 1071710, 1071720, 1071730, 1071740, 1071760, 1071770, 1071780, 1071790, 1071810, 1071830, 1071840, 1071850, 1071860, 1071870, 1071880, 1071900, 1071920, 1071930, 1071940, 1071950, 1071970, 1071980, 1071990, 1072000, 1072050, 1072060, 1072070, 1072080, 1072110, 1072120, 1072130, 1072180, 1072190, 1072200, 1072230, 1072250, 1072260, 1072350, 1072400, 1072410, 1072420, 1072460, 1072470, 1072480, 1072490, 1072500, 1072530, 1072540, 1072550, 1072560, and 1072570,  and Lot Numbers 1062207 through 1071147 (only those lots in this range with the last digit of "7" (seven))

510(k) numbers

not on file

PMA numbers

not on file

Product code

FYA

Firm FEI

1018223

Firm city

Arden

Firm state

NC

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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