Recall Z-0153-2008 ยท FYA Gown, Surgical
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
| Date | Dec 28, 2007 (initiated Sep 14, 2007) |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.