BioPince Full Core Biopsy Instrument packed in aTyvek/plastic blister pack which is labeled as previously stated and als
FDA device recall Z-0952-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Medical Device Technologies, Inc.
- Reason for recall
- The outer plastic blister packagiing material may be cracked thereby compromising the device's sterility barrier.
- Action taken
- The firm mailed a recall letter to accounts on 3/2/2004 asking each account to inspect their in stock product for damage and to to notify the recalling firm and return product. Also the firm enclosed a response card in a self addressed postage paid envelope.
- Root cause
- Other
- Status
- Terminated
- Product code
- GAA
- Quantity affected
- 10,303
- Distribution
- The devices were distributed to 586 domestic medical facilites nationwide and to 13 international accounts.
- Date initiated
- 2004-03-02
- Date posted
- 2004-07-20
- Date terminated
- 2012-07-07
- Location
- Gainesville, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.