American Contract Systems Inc American Contract System Convenience Kits CV B PACK Recall
The recall involves American Contract System Convenience Kits CV B PACK (Model/TNCB10AP) distributed nationwide in the United States, including IA and OH, and containing Medline Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Representative samples did not meet applicable performance specifications. The recall number is Lot 42-8808611, with UDI 191072241252 and expiration date 1/6/2027.
| Brand | American Contract Systems Inc |
|---|---|
| Product | American Contract System Convenience Kits, CV B PACK, Model/Catalog Number: TNCB10AP |
| Reason | The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representative samples did not meet applicable performance specifications. |
| Severity | moderate |
| Units affected | 12 |
| Distribution | US Nationwide distribution in the states of IA, OH. |
| Agency | FDA |
WHAT YOU SHOULD DO
- Identify if your kit is from Lot 42-8808611 and contains the specified components.
- Do not use any affected kits and set them aside in a safe place.
- Contact American Contract Systems Inc for instructions on return, replacement, or disposal of the affected kits.
- If you have used an affected kit or experience issues, consult your healthcare provider for guidance.
How to identify the recalled item
| Lot / date codes | Lot Code: Lot Number: 42-8808611 UDI: 191072241252 Expiration Date: 1/6/2027 |
|---|---|
| Lot / date codes | Lot Code: Lot Number: 70-054952 UDI: 191072219947 |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.