Recall Z-1041-03 ยท FYA Gown, Surgical
Depuy Orthopaedics, Inc.
ProVision Hytrel Universal Hood/Gown; product 5431-31-000
| Date | Jul 23, 2003 (initiated Jun 27, 2003) |
| Status | Terminated |
| Reason | Lack of assurance of sterility, due to the possibility of an incomplete package seal. |
| Root cause | Other |
| Action | An Urgent Recall Notice was sent to customers on June 27, 2003 via federal express. Customers were instructed to locate all affected inventory and to immediately return it to Depuy. |
| Distribution | United States, Australia, Canada, Chile, England, India, Japan, Malaysia, Singapore, South Africa, Taiwan and United Kingdom |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K972832 | PROVISION SURGICAL HELMET SYSTEM Depuy, Inc., Oct 21, 1997 |