Recall Z-0952-04 ยท GAA Needle, Aspiration And Injection, Disposable
Medical Device Technologies, Inc.
BioPince Full Core Biopsy Instrument packed in aTyvek/plastic blister pack which is labeled as previously stated and also in a cardboard shelf carton labeled as MDTECH Gainesville, Florida 32608 BioPince FULL CORE BIOPSY INSTRUMENT ga. cm REF: Lot
| Date | Jul 20, 2004 (initiated Mar 2, 2004) |
| Status | Terminated |
| Reason | The outer plastic blister packagiing material may be cracked thereby compromising the device's sterility barrier. |
| Root cause | Other |
| Action | 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. |
| Quantity | 10,303 |
| Distribution | The devices were distributed to 586 domestic medical facilites nationwide and to 13 international accounts. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.