Reported Oct 22, 2025 · Ongoing
Medical convenience kits Item Number/Description ANCV78BC HEART PACK - 205947 HGCV05K CV SET UP PACK MHPP97AR PACEMAKER…
American Contract Systems Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: American Contract Systems Inc. · 1601 Se Gateway Dr Ste 120 · Grimes, IA · 50111-5223
Is this the product you have?
- Medical convenience kits Item Number/Description ANCV78BC HEART PACK - 205947 HGCV05K CV SET UP PACK MHPP97AR PACEMAKER PACK- 206010 UDBH37AW BASIC HEART PACK - 206044 UHPP82AH PERIPHERAL PACK - 209533 UICD62AN CARDIOVASCUALR SUPPLY (PS 907285) UICT16F CARDIO THORACIC DRAPE PACK (PS 907284) UIVA75I VASCULAR PACK
- Lot codes and dates
10 of 10 products
Products covered by this recall # Barcodes Product as published 1 191072214362ANCV78BB UDI-DI 191072214362 Lot 8133811 Bag serial number 68273380 2 191072235169ANCV78BC UDI-DI 191072235169 Lot 8499811 Bag serial numbers N/A 3 191072212474HGCV05K UDI-DI 191072212474 Lot 8021411 Bag serial number 68154464 4 191072237446MHPP97AR UDI-DI 191072237446 Lot 8527511 Bag serial number N/A 5 191072235299UDBH37AW UDI-DI 191072235299 Lot 8194311 Bag serial numbers 68198334 68198335 6 191072216434UHPP82AH UDI-DI 191072216434 Lot 8112811 Bag serial number N/A 7 191072200495UICD62AN UDI-DI 191072200495 Lot 7999011 Bag serial number N/A 8 191072150431UICT16F UDI-DI 191072150431 Lot 8000411 Bag serial number N/A Lot 8331311 Bag serial number 17627819 Lot 8429011 Bag serial number 17749736 9 191072229052UIVA75I UDI-DI 191072229052 Lot 8056011 Bag serial number N/A 10 191072235602UIVA75J UDI-DI 191072235602 Lot 8422011 Bag serial number 68667536 * If Bag serial number is "n/a", then all of that lot is affected - Amount recalled
- 32,433 total
This recall covers 18 products
The agency filed one notice per product. You are reading one of them; the other 17 are below.
5 more are in the archive.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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