FDA Medical devices recall ·
American Contract System Convenience Kits, CV B PACK, Model recall
- Recall number
- Z-3002-2026
- Date
- (initiated June 29, 2026)
- Company / brand
- American Contract Systems Inc
85 Shaffer Park Dr, Tiffin, OH, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 30 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
American Contract System Convenience Kits, CV B PACK, Model/Catalog Number: TNCB10AP
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot Code: Lot Number: 42-8808611 UDI: 191072241252 Expiration Date: 1/6/2027
Distribution
US Nationwide distribution in the states of IA, OH.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-3002-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.