Recall Z-3120-2011 ยท FKG Tray, Start/Stop (Including Contents), Dialysis
Lee Medical International Inc
Custom dialysis prep kits labeled as follows: KIDNEYCARE, 125/CS, LOT #A1160, EXP 7-12, BIN 35A, Lee Medical International, Inc., New Orleans, LA 70123 MESCALERO-HEMO, 200/CS, LOT #B1113, EXP 8-12, Lee Medical International, Inc., New Orleans, LA 70123 DAV-MT-POCONO-H, 200/CS, LOT #B1123, EXP 8-12, BIN 45B, Lee Medical International, Inc., New Orleans, LA 70123 ADV-CATH-ISL44, 100/CS, LOT #B11
| Date | Sep 7, 2011 (initiated Mar 22, 2011) |
| Status | Terminated |
| Reason | Firm manufactured custom dialysis kits with Povidone Iodine (PVP) Prep Pads which were recalled by H & P industries. Those pads were subsequently recalled due to possible bacterial contamination. |
| Root cause | Material/Component Contamination |
| Action | The firm, Lee Medical International Inc., notified their consignees by email and telephone on 03/22/2011. Consignees were instructed to pull product from stock, quarantine for re-processing, and return or destroy product. Lee Medical arranged for replacement product from alternate manufacturer to be sent to customers. For questions call Production Manager or Operations Manager at 504-734-9336 or email melissal@eleemedical.com or chriss@eleemedical.com. |
| Quantity | 19,625 units |
| Distribution | Nationwide Distribution (USA) - including states of: AZ, CA, FL, GA, MD, NJ, NM, NY, PA, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.