Recall Z-3260-2011 ยท FKG Tray, Start/Stop (Including Contents), Dialysis
Lee Medical International Inc
Custom Dialysis prep kits labeled as follows: ADV-CARE-ISL44, 100/CS, LOT #K1018, EXP 5-12, BIN 34B; COMMUNITY-CATH, 150/CS, LOT #K1052, EXP 5-12, BIN 36B; COLUMBUS-CATH, 50/CS, LOT #1080, EXP 05-12, BIN 39B; RENALSG-CATH, 75/CS, LOT #L1046, EXP 6-12, BIN 40B; SUNYDOWN-HEMO, 100/CS, LOT #l1015, EXP 6-12, BIN 28A; KIDNEYCARE 125/CS, LOT #l1070, EXP 6-12; METHODIST-CATH, 75/CS, LOT #L1072, E
| Date | Sep 23, 2011 (initiated Aug 15, 2011) |
| Status | Terminated |
| Reason | The firm used alcohol triple swabstick and prep pads manufactured by H & P Industries in the manufacture of their custom dialysis kits. Those swabsticks and pads were subsequently recalled due to possible bacterial contamination. |
| Root cause | Nonconforming Material/Component |
| Action | The firm, Lee Medical International Inc., notified their consignees by email and telephone on August 17, 2011. Consignees were instructed to remove the affected 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 | 4,075 units |
| Distribution | Nationwide Distribution (USA) including the states of: CA, FL, GA, IA, LA, MD, NY and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.