Z-3260-2011

Custom Dialysis prep kits labeled as follows: ADV-CARE-ISL44, 100/CS, LOT #K1018, EXP 5-12, BIN 34B...

Name: Z-3260-2011 Custom Dialysis prep kits labeled as follows: ADV-CARE-ISL44, 100/CS, LOT #K1018, EXP 5-12, BIN 34B...
Creator: Lee Medical International Inc
Published: 2011-08-15
License: https://open.fda.gov/license/

Lee Medical International Inc / initiated 2011-08-15 / Terminated / root cause: manufacturing process

FDA source

Lee Medical International Inc began a recall of 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... on 2011-08-15. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3260-2011
Status: Terminated
Initiated: 2011-08-15
Posted: 2011-09-23
Terminated: 2012-01-30
Recalling firm: Lee Medical International Inc
Product: 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, EXP 6-12; METHODIST-HEMO, 150/CS, LOT #L1073, EXP 6-12; MERCYMED-CATH, 75/CS, LOT #L1077, EXP 6-12, BIN 39A and SANTACLA-CATH, 75/CS, LOT #A1118, EXP 7-12, BIN 44A. Product Usage: custom dialysis prep kits
Product code: FKG Tray, Start/Stop (Including Contents), Dialysis
Reason for recall: 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 tag: manufacturing process
FDA 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 [email protected] or [email protected].
Quantity in commerce: 4,075 units
Distribution: Nationwide Distribution (USA) including the states of: CA, FL, GA, IA, LA, MD, NY and TX.
Product codes and lots: 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, EXP 6-12; METHODIST-HEMO, 150/CS, LOT #L1073, EXP 6-12; MERCYMED-CATH, 75/CS, LOT #L1077, EXP 6-12, BIN 39A and SANTACLA-CATH, 75/CS, LOT #A1118, EXP 7-12, BIN 44A.

Product code FKG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)