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
This recall has been terminated (originally issued December 28, 2007).
- Company
- Precept Medical Products, Inc.
- Recall Initiated
- September 14, 2007
- Posted
- December 28, 2007
- Terminated
- September 11, 2009
- Recall Number
- Z-0153-2008
- Quantity
- 11,546,350 (both products-Z-0153/0154-2008)
- Firm Location
- Arden, NC
- Official Source
- View on FDA website ↗
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
Distribution
Worldwide; USA, Australia and Canada
Lot / Code Info
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))
Root Cause
Process control
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.