Recall Z-0881-2008 ยท FMI Needle, Hypodermic, Single Lumen
Popper & Sons Inc
PERFEKTUM TOOMEY EVACUATING SYRINGES, REF/Part # 5047, DESCRIPTION: 30CC LOCK TIP, RX ONLY, NON-STERILE. Manufactured By: Popper & Sons, Inc. New Hyde Park, NY. 11040.
| Date | Feb 12, 2008 (initiated Jan 2, 2008) |
| Status | Terminated |
| Reason | Mis-labeling: the product name on the label was erroneously declared as PERFECTUM TOOMEY EVACUATING SYRINGES instead of POPPER INTERCHANGEABLE HYPODERMIC SYRINGES for one lot of the product. Note: the product information (part number, description, lot number) found in the white box portion of the label is listed correctly. |
| Root cause | Process control |
| Action | The recalling firm, Popper & Sons, began contacting its customers by telephone on/about 1/02/08, informing them of the issue. This was followed up with formal recall letters, Urgent Recall, and response forms starting on 1/09/08 via Certified Mail, Return Receipt Requested to the US accounts, and Registered Mail to the two Canadian accounts. The firm has directed the customers to discontinue using or distributing the lot and return any remaining quantity of this lot of syringes. If the lot has been further distributed, the distributors were instructed to immediately contact their accounts, a |
| Quantity | Domestic - 259 units; Canada - 13 units |
| Distribution | Worldwide-USA including the states of NY, NJ, PA, MI, IL, OH, FL, MO, TX, and CA, and country of Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.