Medical convenience kits IHDC30R D AND C PACK recall
Medical convenience kits IHDC30R D AND C PACK
Why was Medical convenience kits IHDC30R D AND C PACK recalled?
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
IHDC30R UDI-DI 191072226310 lot 8096511 bag serial number N/A * If bag serial number is listed as "N/A", then whole lot is affected
- Product
- Medical convenience kits IHDC30R D AND C PACK
- Recalling firm
- American Contract Systems Inc.
- Quantity
- 32,433 total
- Distribution
- US Nationwide distribution in the states of SD, IA, MN, WA, IL.
- Recall date
- October 22, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)