Cardiac catheterization kit recalled due to sterility concerns
American Contract Systems recalls 460 Cardiac Cath Lab Pack kits due to sterility assurance issues with procedure trays. Facilities should verify affected lots have been removed from clinical use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall involving sterility of an invasive cardiac catheterization procedure kit. While no illnesses or injuries are reported, this represents a risk-of-harm product where sterility failure could cause serious patient infection.
Plain-English summary
American Contract Systems, Inc. is recalling 460 Cardiac Cath Lab Pack-170278 (model GSCC40G) convenience kits due to sterility assurance issues with the procedure trays included in these kits.
The recalled kits were distributed in Arizona. The affected lot can be identified by UDI-DI: 00191072182845 and lot number 9219618, which expires 01/21/2026.
Healthcare facilities that received these kits should verify that affected lots have been removed from clinical use and replaced with non-affected product. Contact American Contract Systems, Inc. for replacement or further information.
The recalled product
- Product
- Brand Name: Banner University Med Ctr. Product Name: Cardiac Cath Lab Pack-170278 Model/Catalog Number: GSCC40G Software Version: N/A Product Description: Convenience Kit Component: No
- Manufacturer
- American Contract Systems, Inc.
- Hazard
- Affected units
- 460
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot Code: UDI-DI: 00191072182845
- Lot: 9219618
- Exp: 01/21/2026
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 3 recalled by American Contract Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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