Recall Z-1113-04 ยท LRO General Surgery Tray
Spinal Specialties, Inc
Gertie Marx PainPak, Lot number 0504305, Reorder number 4060
| Date | Jul 20, 2004 (initiated Jun 18, 2004) |
| Status | Terminated |
| Reason | Kit contains lidocaine, which has particulate matter in its ampule. |
| Root cause | Other |
| Action | Firm notified consignees who received the product by telephone on 6/18/2004, then sent a letter via facsimile and next day air delivery. |
| Quantity | 60 units |
| Distribution | El Paso, Texas and Lansing, Michigan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.