ProVision Barrier Universal Hood/Gown; product 5431-33-000
FDA device recall Z-1042-03 · posted 2003-07-23 · Terminated
Recall details
- Recalling firm
- Depuy Orthopaedics, Inc.
- Reason for recall
- Lack of assurance of sterility, due to the possibility of an incomplete package seal.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- FYA
- Distribution
- United States, Australia, Canada, Chile, England, India, Japan, Malaysia, Singapore, South Africa, Taiwan and United Kingdom
- Date initiated
- 2003-06-27
- Date posted
- 2003-07-23
- Date terminated
- 2004-02-04
- Location
- Warsaw, IN
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